Trial Outcomes & Findings for Effects of Transcranial Electrical Stimulation on Task Performance in Healthy Adults (NCT NCT06995560)
NCT ID: NCT06995560
Last Updated: 2026-05-15
Results Overview
Performance on the ROBoT-r task 15 minutes after completion of tES. Performance is quantified using a weighted composite score. Scores range from 0 to 100, with higher scores indicating better overall task performance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
15 minutes post stimulation
Results posted on
2026-05-15
Participant Flow
Participants were recruited from the greater Boston area. Enrollment occurred between December 1, 2022 and October 10, 2024. All participants were screened for eligibility prior to enrollment
A total of 44 participants provided informed consent and were enrolled. Four participants withdrew prior to assignment to a stimulation group due to scheduling conflicts and did not receive any study intervention. Therefore, 40 participants were assigned to study groups and are included in the participant flow.
Participant milestones
| Measure |
DLPFC: Active to Sham
Participants assigned to left dorsolateral prefrontal cortex (DLPFC) stimulation who received active transcranial electrical stimulation during the first intervention period followed by sham stimulation during the second intervention period in a randomized crossover design.
|
DLPFC: Sham to Active
Participants assigned to left dorsolateral prefrontal cortex (DLPFC) stimulation who received sham stimulation during the first intervention period followed by active transcranial electrical stimulation during the second intervention period in a randomized crossover design.
|
Anterior Insula: Active to Sham
Participants assigned to left anterior insula stimulation who received active transcranial electrical stimulation during the first intervention period followed by sham stimulation during the second intervention period in a randomized crossover design
|
Anterior Insula: Sham to Active
Participants assigned to left anterior insula stimulation who received sham stimulation during the first intervention period followed by active transcranial electrical stimulation during the second intervention period in a randomized crossover design.
|
|---|---|---|---|---|
|
First Intervention Period (Active or Sha
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
First Intervention Period (Active or Sha
STARTED
|
10
|
10
|
10
|
10
|
|
First Intervention Period (Active or Sha
COMPLETED
|
10
|
10
|
10
|
10
|
|
Washout / Interval
STARTED
|
10
|
10
|
10
|
10
|
|
Washout / Interval
COMPLETED
|
10
|
10
|
10
|
10
|
|
Washout / Interval
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention Period (Crossover)
STARTED
|
10
|
10
|
10
|
10
|
|
Second Intervention Period (Crossover)
COMPLETED
|
10
|
10
|
10
|
10
|
|
Second Intervention Period (Crossover)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Transcranial Electrical Stimulation on Task Performance in Healthy Adults
Baseline characteristics by cohort
| Measure |
DLPFC Stimulation Group
n=20 Participants
Participants receive transcranial electrical stimulation (tES) targeting the left dorsolateral prefrontal cortex (DLPFC) and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r) under both active and sham stimulation in a randomized, crossover design.
Active Transcranial Electrical Stimulation: Active tES delivered using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation is applied via high definition electrodes targeting either the left DLPFC or L-aINS at intensities up to 1.9 mA. Stimulation is performed for up to 45 minutes during task execution. Participants perform the ROBoT-r task during stimulation.
Sham Transcranial Electrical Stimulation: Sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
Anterior Insula Stimulation Group
n=20 Participants
Participants receive transcranial electrical stimulation (tES) targeting the left anterior insula and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r) under both active and sham stimulation in a randomized, crossover design.
Active Transcranial Electrical Stimulation: Active tES delivered using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation is applied via high definition electrodes targeting either the left DLPFC or L-aINS at intensities up to 1.9 mA. Stimulation is performed for up to 45 minutes during task execution. Participants perform the ROBoT-r task during stimulation.
Sham Transcranial Electrical Stimulation: Sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 7.9 • n=11 Participants
|
34.5 years
STANDARD_DEVIATION 8.9 • n=9 Participants
|
35.2 years
STANDARD_DEVIATION 8.3 • n=20 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=11 Participants
|
11 Participants
n=9 Participants
|
22 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
18 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=11 Participants
|
20 Participants
n=9 Participants
|
38 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=11 Participants
|
6 Participants
n=9 Participants
|
13 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=11 Participants
|
14 Participants
n=9 Participants
|
27 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=11 Participants
|
20 participants
n=9 Participants
|
40 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after stimulation onsetPopulation: Participants contributed data to both active and sham stimulation conditions within their assigned stimulation target as part of a within-subject crossover design. Outcome data are reported by stimulation target and intervention condition. Inferential effects of stimulation condition, location, session, and difficulty were evaluated using linear mixed-effects regression models accounting for repeated measures within participants.
Performance on the ROBoT-r computerized track-and-capture task assessed using a weighted performance score that integrates accuracy, speed, and task success metrics. Scores are scaled from 0 to 100, with higher scores indicating better performance. Participants used dual-hand controllers to grapple a simulated spacecraft in a time-limited, physics-based environment. Performance was assessed during task execution concurrent with stimulation.
Outcome measures
| Measure |
DLPFC Active
n=20 Participants
Participants received active tES targeting the DLPFC using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation was delivered at intensities up to 1.9 mA for up to 45 minutes during task execution. Outcome measures reflect performance assessed after completion of the stimulation session.
|
DLPFC Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
Anterior Insula Active
n=20 Participants
Participants receive transcranial electrical stimulation (tES) targeting the left anterior insula and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r).
Active Transcranial Electrical Stimulation: Active tES delivered using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation is applied via high definition electrodes targeting either the left DLPFC or L-aINS at intensities up to 1.9 mA. Stimulation is performed for up to 45 minutes during task execution. Participants perform the ROBoT-r task during stimulation.
|
Anterior Insula Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
|---|---|---|---|---|
|
ROBoT-r Task Performance Score (During Stimulation)
|
73.19 score on a scale (0-100)
Standard Deviation 22.25
|
75.33 score on a scale (0-100)
Standard Deviation 21.18
|
76.64 score on a scale (0-100)
Standard Deviation 17.77
|
77.62 score on a scale (0-100)
Standard Deviation 16.52
|
PRIMARY outcome
Timeframe: 15 minutes post stimulationPopulation: Participants contributed data to both active and sham stimulation conditions within their assigned stimulation target as part of a within-subject crossover design. Outcome data are reported by stimulation target and intervention condition. Inferential effects of stimulation condition, location, session, and difficulty were evaluated using linear mixed-effects regression models accounting for repeated measures within participants.
Performance on the ROBoT-r task 15 minutes after completion of tES. Performance is quantified using a weighted composite score. Scores range from 0 to 100, with higher scores indicating better overall task performance.
Outcome measures
| Measure |
DLPFC Active
n=20 Participants
Participants received active tES targeting the DLPFC using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation was delivered at intensities up to 1.9 mA for up to 45 minutes during task execution. Outcome measures reflect performance assessed after completion of the stimulation session.
|
DLPFC Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
Anterior Insula Active
n=20 Participants
Participants receive transcranial electrical stimulation (tES) targeting the left anterior insula and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r).
Active Transcranial Electrical Stimulation: Active tES delivered using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation is applied via high definition electrodes targeting either the left DLPFC or L-aINS at intensities up to 1.9 mA. Stimulation is performed for up to 45 minutes during task execution. Participants perform the ROBoT-r task during stimulation.
|
Anterior Insula Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
|---|---|---|---|---|
|
ROBoT-r Task Performance Score (Post-Stimulation)
|
76.41 score on scale (0-100)
Standard Deviation 18.74
|
77.31 score on scale (0-100)
Standard Deviation 18.42
|
78.80 score on scale (0-100)
Standard Deviation 15.32
|
77.55 score on scale (0-100)
Standard Deviation 16.97
|
PRIMARY outcome
Timeframe: 24 and 48 hours post-stimulationPopulation: All participants who completed the study protocol and contributed ROBoT-r performance data at 24 and/0r 48 hours post-stimulation were included in the analysis. Results are based on mixed-effects regression models accounting for repeated measures within participants.
Performance on ROBoT-r task at 24 and 48 hours after completion of tES. Performance is quantified using a weighted composite score. Scores range from 0 to 100, with higher scores indicating better overall task performance.
Outcome measures
| Measure |
DLPFC Active
n=20 Participants
Participants received active tES targeting the DLPFC using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation was delivered at intensities up to 1.9 mA for up to 45 minutes during task execution. Outcome measures reflect performance assessed after completion of the stimulation session.
|
DLPFC Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
Anterior Insula Active
n=20 Participants
Participants receive transcranial electrical stimulation (tES) targeting the left anterior insula and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r).
Active Transcranial Electrical Stimulation: Active tES delivered using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation is applied via high definition electrodes targeting either the left DLPFC or L-aINS at intensities up to 1.9 mA. Stimulation is performed for up to 45 minutes during task execution. Participants perform the ROBoT-r task during stimulation.
|
Anterior Insula Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
|---|---|---|---|---|
|
ROBoT-r Task Performance Score (Post-Stimulation Follow-up)
48 hours post-stimulation
|
78.59 score on scale (0-100)
Standard Deviation 18.83
|
79.81 score on scale (0-100)
Standard Deviation 15.64
|
78.73 score on scale (0-100)
Standard Deviation 17.20
|
80.74 score on scale (0-100)
Standard Deviation 14.95
|
|
ROBoT-r Task Performance Score (Post-Stimulation Follow-up)
24 hours post-stimulation
|
77.43 score on scale (0-100)
Standard Deviation 18.33
|
78.47 score on scale (0-100)
Standard Deviation 16.41
|
78.40 score on scale (0-100)
Standard Deviation 16.48
|
78.99 score on scale (0-100)
Standard Deviation 17.26
|
SECONDARY outcome
Timeframe: Immediately following each stimulation session (active and sham), up to approximately 45 minutes per session.Population: Participants completed the adverse effects questionnaire following both active and sham stimulation sessions as part of a within-subject crossover design. Adverse effects are reported separately by stimulation target and intervention condition.
Self-reported adverse effects were recorded immediately following the 45-minute stimulation. Participants reported common stimulation-related sensations (e.g., tingling, scalp pain, itching, burning, headache). Effects were recorded for both active and sham stimulation conditions.
Outcome measures
| Measure |
DLPFC Active
n=19 Participants
Participants received active tES targeting the DLPFC using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation was delivered at intensities up to 1.9 mA for up to 45 minutes during task execution. Outcome measures reflect performance assessed after completion of the stimulation session.
|
DLPFC Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
Anterior Insula Active
n=20 Participants
Participants receive transcranial electrical stimulation (tES) targeting the left anterior insula and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r).
Active Transcranial Electrical Stimulation: Active tES delivered using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation is applied via high definition electrodes targeting either the left DLPFC or L-aINS at intensities up to 1.9 mA. Stimulation is performed for up to 45 minutes during task execution. Participants perform the ROBoT-r task during stimulation.
|
Anterior Insula Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
|---|---|---|---|---|
|
tES Adverse Effects Questionnaire
Nausea
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
tES Adverse Effects Questionnaire
Headache
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
tES Adverse Effects Questionnaire
Neck pain
|
0 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
|
tES Adverse Effects Questionnaire
Scalp pain
|
6 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
|
tES Adverse Effects Questionnaire
Tingling
|
11 Participants
|
10 Participants
|
13 Participants
|
12 Participants
|
|
tES Adverse Effects Questionnaire
Itching
|
6 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
|
tES Adverse Effects Questionnaire
Burning sensations
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
tES Adverse Effects Questionnaire
Skin redness
|
6 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
|
tES Adverse Effects Questionnaire
Sleepiness
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
tES Adverse Effects Questionnaire
Trouble Concentrating
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
tES Adverse Effects Questionnaire
Acute Mod Change
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Throughout study sessions when fNIRS was collected (during stimulation and post-stimulation follow-ups).Population: All participants assigned to each stimulation location group with fNIRS data collection were included. This outcome reports data availability (the number of participants with usable fNIRS data) at each stimulation location, rather than hemodynamic activation values.
Functional near-infrared spectroscopy (fNIRS) data were collected during task performance. This outcome reports the number of participants with usable fNIRS data available within each stimulation location group. Hemodynamic activation analyses are not reported here and may be provided in a future update.
Outcome measures
| Measure |
DLPFC Active
n=20 Participants
Participants received active tES targeting the DLPFC using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation was delivered at intensities up to 1.9 mA for up to 45 minutes during task execution. Outcome measures reflect performance assessed after completion of the stimulation session.
|
DLPFC Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
Anterior Insula Active
n=20 Participants
Participants receive transcranial electrical stimulation (tES) targeting the left anterior insula and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r).
Active Transcranial Electrical Stimulation: Active tES delivered using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation is applied via high definition electrodes targeting either the left DLPFC or L-aINS at intensities up to 1.9 mA. Stimulation is performed for up to 45 minutes during task execution. Participants perform the ROBoT-r task during stimulation.
|
Anterior Insula Sham
n=20 Participants
Participants received sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
|
|---|---|---|---|---|
|
fNIRS Data Availability
|
20 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
Adverse Events
DLPFC Active
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
DLPFC Sham
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Anterior Insula Active
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Anterior Insula Sham
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DLPFC Active
n=19 participants at risk
Participants received active high-definition tES targeting the DLPFC while performing the ROBoT-r cognitive-motor task. Stimulation was delivered using the Soterix Medical MXN-33 HD-tES system at intensities up to 1.9 mA for up to 45 minutes
|
DLPFC Sham
n=20 participants at risk
Participants received sham high-definition tES targeting DLPFC while performing the ROBoT-r cognitive-motor task. Sham stimulation used identical electrode placement and ramp-up/down procedures (approximately 20 seconds) without delivering sustained current.
|
Anterior Insula Active
n=20 participants at risk
Participants received active high-definition tES targeting the L-aINS whole performing the ROBoT-r cognitive motor task. Stimulation was delivered using the Soterix Medical MXN-33 HD-tES system at intensities up to 1.9 mA for up to 45 minutes.
|
Anterior Insula Sham
n=20 participants at risk
Participants received sham high-definition tES targeting L-aINS while performing the ROBoT-r cognitive-motor task. Sham stimulation used identical electrode placement and ramp-up/down procedures (approximately 20 seconds) without delivering sustained current.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
15.8%
3/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
10.0%
2/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
15.0%
3/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
10.0%
2/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
5.0%
1/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
25.0%
5/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
25.0%
5/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
General disorders
Scalp Pain
|
31.6%
6/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
25.0%
5/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
35.0%
7/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
30.0%
6/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
Nervous system disorders
Tingling
|
57.9%
11/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
50.0%
10/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
65.0%
13/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
60.0%
12/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
Skin and subcutaneous tissue disorders
Itching
|
31.6%
6/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
25.0%
5/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
35.0%
7/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
30.0%
6/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
General disorders
Burning Sensation
|
10.5%
2/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
10.0%
2/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
15.0%
3/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
15.0%
3/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
Skin and subcutaneous tissue disorders
Skin Redness
|
31.6%
6/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
25.0%
5/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
30.0%
6/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
25.0%
5/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
Nervous system disorders
Sleepiness
|
15.8%
3/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
15.0%
3/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
15.0%
3/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
15.0%
3/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
Nervous system disorders
Trouble Concentrating
|
5.3%
1/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
5.0%
1/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
10.0%
2/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
10.0%
2/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
Psychiatric disorders
Acute Mood Change
|
5.3%
1/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
5.0%
1/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
5.0%
1/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
5.0%
1/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
5.0%
1/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
0.00%
0/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
0.00%
0/20 • Adverse events were monitored throughout all study sessions throughout the 7 study visits across the 2.5-week study timeline. Events were identified through post-session questionnaires and through direct observation by study staff. Any participant-reported symptoms, observed discomfort, and any procedural or device-related issues were documented according to study protocol.
This study used a within-subject crossover design in which participants completed both active and sham stimulation sessions at their assigned stimulation target. Adverse events are reported separately by stimulation target and intervention condition, with participants contributing to both conditions within their assigned target.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place