Trial Outcomes & Findings for Characterizing the Scalp Tolerability of TMS (NCT NCT06354686)
NCT ID: NCT06354686
Last Updated: 2026-08-27
Results Overview
Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which a tactile sensation was first detected during the study session.
COMPLETED
NA
20 participants
During one study session lasting approximately 3 hours.
2026-08-27
Participant Flow
Participants were recruited from the Tallahassee, FL, area and were able to travel to the laboratory. Recruitment methods included flyer distribution, social media, and the FSU Participate in Research webpage.
Of the 20 participants who consented, 18 completed the study procedures and were included in the analysis. One participant discontinued because of scheduling conflicts, and one participant was unable to complete the procedures because of discomfort.
Participant milestones
| Measure |
Single Arm
This study characterized the tolerability of TMS by stimulation location, including modified BeamF3 prefrontal, THREE-D prefrontal, right orbitofrontal, medial prefrontal, motor, parietal cortical, and knee locations, and by stimulation frequency, including 1 Hz, 10 Hz, and iTBS, at increasing stimulation intensities. The study also characterized sensory thresholds and qualitative aspects of stimulation across locations and frequencies.
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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18
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Single Arm
This study characterized the tolerability of TMS by stimulation location, including modified BeamF3 prefrontal, THREE-D prefrontal, right orbitofrontal, medial prefrontal, motor, parietal cortical, and knee locations, and by stimulation frequency, including 1 Hz, 10 Hz, and iTBS, at increasing stimulation intensities. The study also characterized sensory thresholds and qualitative aspects of stimulation across locations and frequencies.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Participant age at enrollment.
Baseline characteristics by cohort
| Measure |
Single Arm
n=18 Participants
The 18 participants who completed the study procedures and were included in the analysis provided baseline demographic and clinical information.
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Age, Continuous
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34.8 years
STANDARD_DEVIATION 21.6 • n=18 Participants • Participant age at enrollment.
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Sex: Female, Male
Female
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12 Participants
n=18 Participants
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Sex: Female, Male
Male
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6 Participants
n=18 Participants
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Region of Enrollment
United States
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18 Participants
n=18 Participants
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Patient Health Questionnaire-9
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2.8 points
STANDARD_DEVIATION 4.4 • n=18 Participants
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Generalized Anxiety Disorder-7 Score
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2.8 points
STANDARD_DEVIATION 4.6 • n=18 Participants
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PRIMARY outcome
Timeframe: During one study session lasting approximately 3 hours.Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which a tactile sensation was first detected during the study session.
Outcome measures
| Measure |
Single Arm
n=18 Participants
Participants who completed sensory-threshold testing.
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|---|---|
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Sensory Threshold
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40.2 percentage of sMT
Standard Deviation 9.4
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PRIMARY outcome
Timeframe: During one study session lasting approximately 3 hours.Stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), at which the tactile sensation was first perceived as annoying during the study session.
Outcome measures
| Measure |
Single Arm
n=18 Participants
Participants who completed sensory-threshold testing.
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|---|---|
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Annoyance Threshold
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87.6 percentage of sMT
Standard Deviation 29.1
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PRIMARY outcome
Timeframe: During one study session lasting approximately 3 hours.Maximum stimulation intensity, expressed as a percentage of the standardized motor threshold (sMT), tolerated before the stimulation was rated as troublesome or miserable during the study session.
Outcome measures
| Measure |
Single Arm
n=18 Participants
Participants who completed sensory-threshold testing.
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|---|---|
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Tolerability Threshold
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111.5 percentage of sMT
Standard Deviation 28.5
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Adverse Events
Single Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm
n=20 participants at risk
Adverse events that occurred during the study session.
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|---|---|
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General disorders
Discomfort
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5.0%
1/20 • Number of events 1 • During one study session lasting approximately 3 hours.
Adverse events were assessed during the single study session. Events were recorded when reported by a participant or observed by study personnel.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place