Trial Outcomes & Findings for Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC) (NCT NCT05092516)
NCT ID: NCT05092516
Last Updated: 2026-04-30
Results Overview
Performance during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.
ACTIVE_NOT_RECRUITING
NA
31 participants
Baseline
2026-04-30
Participant Flow
Participant milestones
| Measure |
Active tDCS
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)
Baseline characteristics by cohort
| Measure |
Active tDCS
n=16 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=15 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 15 • n=14 Participants
|
43.1 years
STANDARD_DEVIATION 10.5 • n=34 Participants
|
44.7 years
STANDARD_DEVIATION 12.9 • n=69 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=14 Participants
|
12 Participants
n=34 Participants
|
23 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
8 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=14 Participants
|
14 Participants
n=34 Participants
|
28 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=14 Participants
|
14 Participants
n=34 Participants
|
29 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=14 Participants
|
15 Participants
n=34 Participants
|
31 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Data for this outcome were missing at either baseline or posttreatment time points for 3 participants.
Performance during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.
Outcome measures
| Measure |
Active tDCS
n=10 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=11 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Inhibitory Control
|
0.80 Ratio of correct responses
Standard Deviation 0.08
|
0.79 Ratio of correct responses
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: Posttreatment (1 month follow-up)Population: Data for this outcome were missing at either baseline or posttreatment time points for 3 participants.
Performance during the incongruent trials of the Eriksen Flanker Task were assessed approximately approximately 4-weeks after baseline. The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.
Outcome measures
| Measure |
Active tDCS
n=10 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=11 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Inhibitory Control
|
0.84 Ratio of correct responses
Standard Deviation 0.09
|
0.82 Ratio of correct responses
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: BaselinePopulation: Data for this outcome were missing at either baseline or posttreatment time points for 3 participants.
Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention)
Outcome measures
| Measure |
Active tDCS
n=10 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=11 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Processing Speed
|
424.1 miliseconds
Standard Deviation 39
|
406.9 miliseconds
Standard Deviation 42.7
|
PRIMARY outcome
Timeframe: Posttreatment (1 month follow-up)Population: Data for this outcome were missing at either baseline or posttreatment time points for 3 participants.
Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline.
Outcome measures
| Measure |
Active tDCS
n=10 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=11 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Processing Speed
|
412.3 miliseconds
Standard Deviation 35.8
|
403.9 miliseconds
Standard Deviation 38.9
|
PRIMARY outcome
Timeframe: BaselinePopulation: Data for this outcome were missing at either baseline or posttreatment time points for 4 participants.
EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.
Outcome measures
| Measure |
Active tDCS
n=9 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=11 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
EEG P300 Event-related Potential
|
0.59 microvolts
Standard Deviation 0.50
|
0.64 microvolts
Standard Deviation 0.38
|
PRIMARY outcome
Timeframe: Posttreatment (1 month follow-up)Population: Data for this outcome were missing at either baseline or posttreatment time points for 4 participants.
EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline. EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.
Outcome measures
| Measure |
Active tDCS
n=9 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=11 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
EEG P300 Event-related Potential
|
0.62 microvolts
Standard Deviation 0.63
|
0.85 microvolts
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: BaselinePerformance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.
Outcome measures
| Measure |
Active tDCS
n=12 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=12 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Cognitive Flexibility
|
41.4 Performance score (higher the better)
Standard Deviation 11.7
|
40 Performance score (higher the better)
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Posttreatment (1 month follow-up)Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.
Outcome measures
| Measure |
Active tDCS
n=12 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=12 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Cognitive Flexibility
|
47.5 Performance score (higher the better)
Standard Deviation 10.6
|
44.1 Performance score (higher the better)
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: BaselinePerformance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.
Outcome measures
| Measure |
Active tDCS
n=12 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=12 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Working Memory
|
46.9 Performance score (higher the better)
Standard Deviation 8.7
|
43.7 Performance score (higher the better)
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Posttreatment (1 month follow-up)Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.
Outcome measures
| Measure |
Active tDCS
n=12 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=12 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Working Memory
|
52.1 Performance score (higher the better)
Standard Deviation 7.7
|
50.1 Performance score (higher the better)
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: BaselinePerformance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.
Outcome measures
| Measure |
Active tDCS
n=12 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=12 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Episodic Memory
|
56.4 Performance score (higher the better)
Standard Deviation 11.9
|
52.5 Performance score (higher the better)
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Posttreatment (1 month follow-up)Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.
Outcome measures
| Measure |
Active tDCS
n=12 Participants
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=12 Participants
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
Episodic Memory
|
59.1 Performance score (higher the better)
Standard Deviation 12.2
|
57.5 Performance score (higher the better)
Standard Deviation 18
|
Adverse Events
Active tDCS
Sham tDCS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS
n=16 participants at risk
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
Sham tDCS
n=15 participants at risk
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
|
|---|---|---|
|
General disorders
Warmth sensation
|
6.2%
1/16 • from baseline until end of treatment (4-weeks)
|
13.3%
2/15 • from baseline until end of treatment (4-weeks)
|
|
General disorders
Distractibility
|
31.2%
5/16 • from baseline until end of treatment (4-weeks)
|
40.0%
6/15 • from baseline until end of treatment (4-weeks)
|
|
General disorders
Headache
|
6.2%
1/16 • from baseline until end of treatment (4-weeks)
|
26.7%
4/15 • from baseline until end of treatment (4-weeks)
|
|
General disorders
Neck pain
|
6.2%
1/16 • from baseline until end of treatment (4-weeks)
|
6.7%
1/15 • from baseline until end of treatment (4-weeks)
|
|
General disorders
Scalp pain
|
6.2%
1/16 • from baseline until end of treatment (4-weeks)
|
0.00%
0/15 • from baseline until end of treatment (4-weeks)
|
|
General disorders
Skin tingling
|
6.2%
1/16 • from baseline until end of treatment (4-weeks)
|
13.3%
2/15 • from baseline until end of treatment (4-weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place