Trial Outcomes & Findings for Theta Phase-specific TMS to Modulate Prefrontal Activity (NCT NCT05416138)
NCT ID: NCT05416138
Last Updated: 2025-12-10
Results Overview
Reaction time (in milliseconds) in the Approach/Avoidance task during transcranial magnetic stimulation (TMS). TMS was synchronized to either the peaks or troughs of the participant's left prefrontal theta waves, in a randomized and counterbalanced order. The preregistered primary outcome measure is the average difference in reaction times between peak- and trough-synchronized stimulation stimuli. This statistical contrast specifically highlights the role of theta phase in phase-aligned stimulation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
During the stimulation/task for each condition (approximately 6 minutes per run, 4 runs per condition).
Results posted on
2025-12-10
Participant Flow
Participant milestones
| Measure |
TMS Over the Prefrontal Cortex Followed by TMS Over the Head Vertex.
Transcranial magnetic stimulation (TMS) was first applied to the left dorsolateral prefrontal cortex (Condition 1) and then to the vertex of the head (Condition 2) at an intensity of up to 120% of the individualized resting motor threshold. During both conditions, participants performed the Approach/Avoidance task, which included the presentation of emotional stimuli. Each stimulus was accompanied by a simultaneous burst of TMS pulses, synchronized to either the peaks or troughs of the participant's left prefrontal theta waves (in randomized, interleaved order). Participants responded to each stimulus with a joystick movement (which should have been either congruent or incongruent as per the task hint, in randomized, interleaved order). The primary outcome measure was the difference in responses during TMS synchronized to theta wave peaks versus troughs.
|
TMS Over the Head Vertex Followed by TMS Over the Prefrontal Cortex.
Transcranial magnetic stimulation (TMS) was first applied to the vertex of the head (Condition2) and then to the left dorsolateral prefrontal cortex (Condition 1) at an intensity of up to 120% of the individualized resting motor threshold. During both conditions, participants performed the Approach/Avoidance task, which included the presentation of emotional stimuli. Each stimulus was accompanied by a simultaneous burst of TMS pulses, synchronized to either the peaks or troughs of the participant's left prefrontal theta waves (in randomized, interleaved order). Participants responded to each stimulus with a joystick movement (which should have been either congruent or incongruent as per the task hint, in randomized, interleaved order). The primary outcome measure was the difference in responses during TMS synchronized to theta wave peaks versus troughs.
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|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
TMS Over the Prefrontal Cortex Followed by TMS Over the Head Vertex.
Transcranial magnetic stimulation (TMS) was first applied to the left dorsolateral prefrontal cortex (Condition 1) and then to the vertex of the head (Condition 2) at an intensity of up to 120% of the individualized resting motor threshold. During both conditions, participants performed the Approach/Avoidance task, which included the presentation of emotional stimuli. Each stimulus was accompanied by a simultaneous burst of TMS pulses, synchronized to either the peaks or troughs of the participant's left prefrontal theta waves (in randomized, interleaved order). Participants responded to each stimulus with a joystick movement (which should have been either congruent or incongruent as per the task hint, in randomized, interleaved order). The primary outcome measure was the difference in responses during TMS synchronized to theta wave peaks versus troughs.
|
TMS Over the Head Vertex Followed by TMS Over the Prefrontal Cortex.
Transcranial magnetic stimulation (TMS) was first applied to the vertex of the head (Condition2) and then to the left dorsolateral prefrontal cortex (Condition 1) at an intensity of up to 120% of the individualized resting motor threshold. During both conditions, participants performed the Approach/Avoidance task, which included the presentation of emotional stimuli. Each stimulus was accompanied by a simultaneous burst of TMS pulses, synchronized to either the peaks or troughs of the participant's left prefrontal theta waves (in randomized, interleaved order). Participants responded to each stimulus with a joystick movement (which should have been either congruent or incongruent as per the task hint, in randomized, interleaved order). The primary outcome measure was the difference in responses during TMS synchronized to theta wave peaks versus troughs.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Theta Phase-specific TMS to Modulate Prefrontal Activity
Baseline characteristics by cohort
| Measure |
All Participants
n=26 Participants
All 26 participants consented in this study
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the stimulation/task for each condition (approximately 6 minutes per run, 4 runs per condition).Population: Cross-over study - all participants were in both arms at different timepoints
Reaction time (in milliseconds) in the Approach/Avoidance task during transcranial magnetic stimulation (TMS). TMS was synchronized to either the peaks or troughs of the participant's left prefrontal theta waves, in a randomized and counterbalanced order. The preregistered primary outcome measure is the average difference in reaction times between peak- and trough-synchronized stimulation stimuli. This statistical contrast specifically highlights the role of theta phase in phase-aligned stimulation.
Outcome measures
| Measure |
TMS Over the Left Prefrontal Cortex
n=23 Participants
Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the left dorsolateral prefrontal cortex (DLPFC) at the intensity of up to 120% of the individualized resting motor threshold (rMT).
Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing and stimulation per session is approximately 40 minutes (in 4 blocks with breaks in-between).
Transcranial magnetic stimulation (TMS): TMS will be performed at either peaks or troughs of ongoing prefrontal theta oscillations (3-7 Hz) concurrently with the cognitive test at the beginning of every test trial. Theta oscillations will be monitored in real-time at the left dorsolateral prefrontal cortex using electroencephalography (EEG).
|
TMS Over the Head Vertex
n=23 Participants
Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the head vertex at the intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing per session is approximately 40 minutes (in 4 blocks with breaks in-between). Transcranial magnetic stimulation (TMS): TMS will be performed at either peaks or troughs of ongoing prefrontal theta oscillations (3-7 Hz) concurrently with the cognitive test at the beginning of every test trial. Theta oscillations will be monitored in real-time at the left dorsolateral prefrontal cortex using electroencephalography (EEG).
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|---|---|---|
|
Reaction Times in the Approach/Avoidance Test
|
36.8 milliseconds
Standard Error 16.3
|
12.4 milliseconds
Standard Error 21.2
|
SECONDARY outcome
Timeframe: During the stimulation/task for each condition (approximately 6 minutes per run, 4 runs per condition).Amplitude of transcranial magnetic stimulation (TMS)-evoked potentials (in microvolts) in ongoing electroencephalography (EEG) in the left prefrontal cortex during the TMS synchronized to either peaks or troughs of the participant's left prefrontal theta waves. The preregistered secondary outcome measure is the average difference in early absolute evoked potentials between peak- and trough-synchronized stimulation epochs. This statistical contrast specifically highlights the phase-specific effect of theta phase-aligned stimulation.
Outcome measures
| Measure |
TMS Over the Left Prefrontal Cortex
n=23 Participants
Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the left dorsolateral prefrontal cortex (DLPFC) at the intensity of up to 120% of the individualized resting motor threshold (rMT).
Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing and stimulation per session is approximately 40 minutes (in 4 blocks with breaks in-between).
Transcranial magnetic stimulation (TMS): TMS will be performed at either peaks or troughs of ongoing prefrontal theta oscillations (3-7 Hz) concurrently with the cognitive test at the beginning of every test trial. Theta oscillations will be monitored in real-time at the left dorsolateral prefrontal cortex using electroencephalography (EEG).
|
TMS Over the Head Vertex
n=23 Participants
Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the head vertex at the intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing per session is approximately 40 minutes (in 4 blocks with breaks in-between). Transcranial magnetic stimulation (TMS): TMS will be performed at either peaks or troughs of ongoing prefrontal theta oscillations (3-7 Hz) concurrently with the cognitive test at the beginning of every test trial. Theta oscillations will be monitored in real-time at the left dorsolateral prefrontal cortex using electroencephalography (EEG).
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|---|---|---|
|
Amplitude of TMS Evoked Potentials
|
1.3 microvolts
Standard Deviation 1.9
|
0.2 microvolts
Standard Deviation 1.1
|
Adverse Events
TMS Over the Prefrontal Cortex Followed by TMS Over the Head Vertex.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TMS Over the Head Vertex Followed by TMS Over the Prefrontal Cortex.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place