Trial Outcomes & Findings for Individualized Closed Loop TMS for Working Memory Enhancement (NCT NCT04402294)

NCT ID: NCT04402294

Last Updated: 2025-07-17

Results Overview

During the TMS/fMRI scan, participants perform a working memory task (N-back). To evaluate how different repetitive TMS frequencies (5, 10, and 20 Hz) impact reaction time during N-back task, each rTMS train is followed by a block of the N-back task. A decoder identifies one frequency as optimal frequency and another as suboptimal frequency. Reaction Time during optimal, suboptimal, and no stimulation condition is assessed by taking average of reaction time on accurate trials with faster reaction times indicating better performance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Single visit (~2 hours)

Results posted on

2025-07-17

Participant Flow

Of the 27 participants enrolled in the study, 2 withdrew before group assignment during the baseline MRI visit; one due to MRI-related discomfort and one due to scheduling conflicts.

Participant milestones

Participant milestones
Measure
Optimized TMS Frequency, Then Sub-Optimal TMS Frequency
In the first neuromodulation session, participants will receive rTMS using their optimal TMS frequency. After washout period of 1 week (minimum), the participants will start their second neuromodulation session using their sub-optimal TMS frequency instead. Repetitive Transcranial Magnetic Stimulation (rTMS): The investigators will create individualized TMS targets using deep learning methods on task and resting fMRI data to target working memory augmentation. The individualized target will be stimulated in a subsequent fMRI scan involving working memory task performance interleaved with repetitive TMS (rTMS) delivered at a variety of stimulation frequencies. Based on activation readouts in response to rTMS, an optimal and sub-optimal brain state frequency to impact working memory performance will be selected for each participant. Participants will receive rTMS at each frequency separately for three days (six days total), with the order of frequency randomly assigned and counterbalanced. Following each three day protocol, another fMRI working memory readout will be conducted to support the targeting and frequency selection algorithms.
Sub-Optimal TMS Frequency, Then Optimized TMS Frequency
In the first neuromodulation session, participants will receive rTMS using their sub-optimal TMS frequency. After washout period of 1 week (minimum), the participants will start their second neuromodulation session using their optimal TMS frequency instead. Repetitive Transcranial Magnetic Stimulation (rTMS): The investigators will create individualized TMS targets using deep learning methods on task and resting fMRI data to target working memory augmentation. The individualized target will be stimulated in a subsequent fMRI scan involving working memory task performance interleaved with repetitive TMS (rTMS) delivered at a variety of stimulation frequencies. Based on activation readouts in response to rTMS, an optimal and sub-optimal brain state frequency to impact working memory performance will be selected for each participant. Participants will receive rTMS at each frequency separately for three days (six days total), with the order of frequency randomly assigned and counterbalanced. Following each three day protocol, another fMRI working memory readout will be conducted to support the targeting and frequency selection algorithms.
Neuromodulation Week 1 (V4-V6)
STARTED
13
12
Neuromodulation Week 1 (V4-V6)
COMPLETED
13
12
Neuromodulation Week 1 (V4-V6)
NOT COMPLETED
0
0
TMS/fMRI #2 (Visit 7)
STARTED
13
12
TMS/fMRI #2 (Visit 7)
COMPLETED
13
12
TMS/fMRI #2 (Visit 7)
NOT COMPLETED
0
0
Washout (at Least 7 Days)
STARTED
13
12
Washout (at Least 7 Days)
COMPLETED
12
11
Washout (at Least 7 Days)
NOT COMPLETED
1
1
Neuromodulation Week 2 (V8 - V10)
STARTED
12
11
Neuromodulation Week 2 (V8 - V10)
COMPLETED
12
11
Neuromodulation Week 2 (V8 - V10)
NOT COMPLETED
0
0
TMS/fMRI #3 (Visit 11)
STARTED
12
11
TMS/fMRI #3 (Visit 11)
COMPLETED
12
11
TMS/fMRI #3 (Visit 11)
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Optimized TMS Frequency, Then Sub-Optimal TMS Frequency
In the first neuromodulation session, participants will receive rTMS using their optimal TMS frequency. After washout period of 1 week (minimum), the participants will start their second neuromodulation session using their sub-optimal TMS frequency instead. Repetitive Transcranial Magnetic Stimulation (rTMS): The investigators will create individualized TMS targets using deep learning methods on task and resting fMRI data to target working memory augmentation. The individualized target will be stimulated in a subsequent fMRI scan involving working memory task performance interleaved with repetitive TMS (rTMS) delivered at a variety of stimulation frequencies. Based on activation readouts in response to rTMS, an optimal and sub-optimal brain state frequency to impact working memory performance will be selected for each participant. Participants will receive rTMS at each frequency separately for three days (six days total), with the order of frequency randomly assigned and counterbalanced. Following each three day protocol, another fMRI working memory readout will be conducted to support the targeting and frequency selection algorithms.
Sub-Optimal TMS Frequency, Then Optimized TMS Frequency
In the first neuromodulation session, participants will receive rTMS using their sub-optimal TMS frequency. After washout period of 1 week (minimum), the participants will start their second neuromodulation session using their optimal TMS frequency instead. Repetitive Transcranial Magnetic Stimulation (rTMS): The investigators will create individualized TMS targets using deep learning methods on task and resting fMRI data to target working memory augmentation. The individualized target will be stimulated in a subsequent fMRI scan involving working memory task performance interleaved with repetitive TMS (rTMS) delivered at a variety of stimulation frequencies. Based on activation readouts in response to rTMS, an optimal and sub-optimal brain state frequency to impact working memory performance will be selected for each participant. Participants will receive rTMS at each frequency separately for three days (six days total), with the order of frequency randomly assigned and counterbalanced. Following each three day protocol, another fMRI working memory readout will be conducted to support the targeting and frequency selection algorithms.
Washout (at Least 7 Days)
Withdrawal by Subject
1
0
Washout (at Least 7 Days)
Insufficient study funds to continue with their participation.
0
1

Baseline Characteristics

Individualized Closed Loop TMS for Working Memory Enhancement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Optimized TMS Frequency, Then Sub-Optimal TMS Frequency
n=12 Participants
In the first neuromodulation session, participants will receive rTMS using their optimal TMS frequency. After washout period of 1 week (minimum), the participants will start their second neuromodulation session using their sub-optimal TMS frequency instead. Repetitive Transcranial Magnetic Stimulation (rTMS): The investigators will create individualized TMS targets using deep learning methods on task and resting fMRI data to target working memory augmentation. The individualized target will be stimulated in a subsequent fMRI scan involving working memory task performance interleaved with repetitive TMS (rTMS) delivered at a variety of stimulation frequencies. Based on activation readouts in response to rTMS, an optimal and sub-optimal brain state frequency to impact working memory performance will be selected for each participant. Participants will receive rTMS at each frequency separately for three days (six days total), with the order of frequency randomly assigned and counterbalanced. Following each three day protocol, another fMRI working memory readout will be conducted to support the targeting and frequency selection algorithms.
Sub-Optimal TMS Frequency, Then Optimized TMS Frequency
n=11 Participants
In the first neuromodulation session, participants will receive rTMS using their sub-optimal TMS frequency. After washout period of 1 week (minimum), the participants will start their second neuromodulation session using their optimal TMS frequency instead. Repetitive Transcranial Magnetic Stimulation (rTMS): The investigators will create individualized TMS targets using deep learning methods on task and resting fMRI data to target working memory augmentation. The individualized target will be stimulated in a subsequent fMRI scan involving working memory task performance interleaved with repetitive TMS (rTMS) delivered at a variety of stimulation frequencies. Based on activation readouts in response to rTMS, an optimal and sub-optimal brain state frequency to impact working memory performance will be selected for each participant. Participants will receive rTMS at each frequency separately for three days (six days total), with the order of frequency randomly assigned and counterbalanced. Following each three day protocol, another fMRI working memory readout will be conducted to support the targeting and frequency selection algorithms.
Total
n=23 Participants
Total of all reporting groups
Age, Continuous
28.51 years
STANDARD_DEVIATION 5.98 • n=5 Participants
22.67 years
STANDARD_DEVIATION 3.91 • n=7 Participants
25.43 years
STANDARD_DEVIATION 5.71 • n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
5 Participants
n=7 Participants
11 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
White
9 Participants
n=5 Participants
7 Participants
n=7 Participants
16 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
12 Participants
n=5 Participants
11 Participants
n=7 Participants
23 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Single visit (~2 hours)

Population: All 19 participants underwent three different stimulation periods including Optimal, Suboptimal, and No Stimulation. Four subjects who completed the study were not included in the analysis due to technical issues leading to unreliable or missing data.

During the TMS/fMRI scan, participants perform a working memory task (N-back). To evaluate how different repetitive TMS frequencies (5, 10, and 20 Hz) impact reaction time during N-back task, each rTMS train is followed by a block of the N-back task. A decoder identifies one frequency as optimal frequency and another as suboptimal frequency. Reaction Time during optimal, suboptimal, and no stimulation condition is assessed by taking average of reaction time on accurate trials with faster reaction times indicating better performance.

Outcome measures

Outcome measures
Measure
N-Back Performance During Optimal Stimulation
n=19 Participants
Participants underwent optimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During Suboptimal Stimulation
n=19 Participants
Participants underwent suboptimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During No Stimulation
n=19 Participants
Participants also underwent periods of No Stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
Suboptimal Neuromodulation Day-1
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-1 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-2
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-2 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-3
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-3 of Suboptimal Stimulation.
Reaction Time Changes During N-Back Task in Responses to Different TMS Frequencies
0.5853 Seconds
Standard Deviation 0.0980
0.5978 Seconds
Standard Deviation 0.1496
0.6012 Seconds
Standard Deviation 0.0961

PRIMARY outcome

Timeframe: Single visit (~2 hours)

Population: All 19 participants underwent three different stimulation periods including Optimal, Suboptimal, and No Stimulation. Four subjects who completed the study were not included in the analysis due to technical issues leading to unreliable or missing data.

During the TMS/fMRI scan, participants perform a working memory task (N-back). To evaluate how different repetitive TMS frequencies (5, 10, and 20 Hz) impact accuracy during N-back task, each rTMS train is followed by a block of the N-back task. A decoder identifies one frequency as optimal frequency and another as suboptimal frequency. Accuracy during optimal, suboptimal, and no stimulation condition is assessed by taking average of all the trials with better accuracy indicating better performance.

Outcome measures

Outcome measures
Measure
N-Back Performance During Optimal Stimulation
n=19 Participants
Participants underwent optimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During Suboptimal Stimulation
n=19 Participants
Participants underwent suboptimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During No Stimulation
n=19 Participants
Participants also underwent periods of No Stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
Suboptimal Neuromodulation Day-1
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-1 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-2
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-2 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-3
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-3 of Suboptimal Stimulation.
Accuracy Changes During N-Back Task in Responses to Different TMS Frequencies
91.27 Percentage
Standard Error 16.30
90.71 Percentage
Standard Error 12.87
90.54 Percentage
Standard Error 13.14

PRIMARY outcome

Timeframe: Up to 1 month

Population: Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. the DMTS task consisted of three conditions including 0 sec, 4 sec, and 12 sec delay conditions. Four subjects who completed the study were not included in the analysis due to technical issues leading to unreliable or missing data.

Each subject completes two 3-day neuromodulation sessions, one using their 'optimal' rTMS frequency, and the other using their 'suboptimal' rTMS frequency, as determined by their TMS/fMRI visit. After each neuromodulation session, subjects complete a working memory task (Delayed Match to Sample). The delay period reflects how long participants can retain the information in working memory. Common delay periods used in research, including our study, are 0 seconds, 4 seconds, and 12 seconds.The outcome measure shows the reaction time for each of these variables.

Outcome measures

Outcome measures
Measure
N-Back Performance During Optimal Stimulation
n=19 Participants
Participants underwent optimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During Suboptimal Stimulation
n=19 Participants
Participants underwent suboptimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During No Stimulation
n=19 Participants
Participants also underwent periods of No Stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
Suboptimal Neuromodulation Day-1
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-1 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-2
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-2 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-3
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-3 of Suboptimal Stimulation.
Reaction Time Changes in the Delayed Matching to Sample Task Following Optimal vs. Suboptimal rTMS Stimulation
Reaction Time (0 sec delay)
2.0173 Reaction Time (sec)
Standard Error 0.1423
1.7568 Reaction Time (sec)
Standard Error 0.0890
1.9316 Reaction Time (sec)
Standard Error 0.1862
2.0608 Reaction Time (sec)
Standard Error 0.1542
1.9118 Reaction Time (sec)
Standard Error 0.1068
1.9139 Reaction Time (sec)
Standard Error 0.1163
Reaction Time Changes in the Delayed Matching to Sample Task Following Optimal vs. Suboptimal rTMS Stimulation
Reaction Time (4 sec delay)
2.6640 Reaction Time (sec)
Standard Error 0.1936
2.4269 Reaction Time (sec)
Standard Error 0.1537
2.1726 Reaction Time (sec)
Standard Error 0.1292
2.3907 Reaction Time (sec)
Standard Error 0.1615
2.3268 Reaction Time (sec)
Standard Error 0.1694
2.4788 Reaction Time (sec)
Standard Error 0.2135
Reaction Time Changes in the Delayed Matching to Sample Task Following Optimal vs. Suboptimal rTMS Stimulation
Reaction Time (12 sec delay)
2.7351 Reaction Time (sec)
Standard Error 0.1588
2.5593 Reaction Time (sec)
Standard Error 0.1995
2.4400 Reaction Time (sec)
Standard Error 0.1602
2.4901 Reaction Time (sec)
Standard Error 0.1377
2.5741 Reaction Time (sec)
Standard Error 0.2054
2.6478 Reaction Time (sec)
Standard Error 0.2501

PRIMARY outcome

Timeframe: Up to 1 month

Each subject completes two 3-day neuromodulation sessions, one using their 'optimal' rTMS frequency, and the other using their 'suboptimal' rTMS frequency, as determined by their TMS/fMRI visit. After each neuromodulation session, subjects complete a working memory task (Delayed Match to Sample). The delay period reflects how long participants can retain the information in working memory. Common delay periods used in research, including our study, are 0 seconds, 4 seconds, and 12 seconds.The outcome measure shows the accuracy for each of these variables.

Outcome measures

Outcome measures
Measure
N-Back Performance During Optimal Stimulation
n=19 Participants
Participants underwent optimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During Suboptimal Stimulation
n=19 Participants
Participants underwent suboptimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During No Stimulation
n=19 Participants
Participants also underwent periods of No Stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
Suboptimal Neuromodulation Day-1
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-1 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-2
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-2 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-3
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-3 of Suboptimal Stimulation.
Accuracy Changes in the Delayed Matching to Sample Task Following Optimal vs. Suboptimal rTMS Stimulation
Accuracy (0 sec delay)
84.2667 Percentage
Standard Error 3.2161
88.1011 Percentage
Standard Error 2.0073
83.9079 Percentage
Standard Error 3.6464
86.0638 Percentage
Standard Error 2.7408
87.8524 Percentage
Standard Error 2.3671
84.3748 Percentage
Standard Error 2.8921
Accuracy Changes in the Delayed Matching to Sample Task Following Optimal vs. Suboptimal rTMS Stimulation
Accuracy (4 sec delay)
79.5037 Percentage
Standard Error 2.6388
78.1085 Percentage
Standard Error 2.7024
84.4127 Percentage
Standard Error 2.8358
78.2541 Percentage
Standard Error 3.0680
81.3003 Percentage
Standard Error 3.5756
77.5741 Percentage
Standard Error 2.8761
Accuracy Changes in the Delayed Matching to Sample Task Following Optimal vs. Suboptimal rTMS Stimulation
Accuracy (12 sec delay)
79.4809 Percentage
Standard Error 2.7578
77.6172 Percentage
Standard Error 3.0897
88.0465 Percentage
Standard Error 2.5656
76.4133 Percentage
Standard Error 3.4818
76.1351 Percentage
Standard Error 3.1626
79.9014 Percentage
Standard Error 3.4101

SECONDARY outcome

Timeframe: Up to 1 month

Each subject completes two 3-day neuromodulation sessions, one using their 'optimal' rTMS frequency, and the other using their 'suboptimal' rTMS frequency, as determined by their TMS/fMRI visit. After each neuromodulation session, subjects complete a reaction time index task that acted as a control task. The outcome measure shows the reaction time.

Outcome measures

Outcome measures
Measure
N-Back Performance During Optimal Stimulation
n=19 Participants
Participants underwent optimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During Suboptimal Stimulation
n=19 Participants
Participants underwent suboptimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During No Stimulation
n=19 Participants
Participants also underwent periods of No Stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
Suboptimal Neuromodulation Day-1
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-1 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-2
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-2 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-3
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-3 of Suboptimal Stimulation.
Reaction Time Changes in the Reaction Time Index Task Following Optimal vs. Suboptimal rTMS Stimulation
0.716 Seconds
Standard Deviation 0.072
0.722 Seconds
Standard Deviation 0.108
0.687 Seconds
Standard Deviation 0.085
0.736 Seconds
Standard Deviation 0.117
0.713 Seconds
Standard Deviation 0.102
0.693 Seconds
Standard Deviation 0.093

SECONDARY outcome

Timeframe: Up to 1 month

Each subject completes two 3-day neuromodulation sessions, one using their 'optimal' rTMS frequency, and the other using their 'suboptimal' rTMS frequency, as determined by their TMS/fMRI visit. After each neuromodulation session, subjects complete a reaction time index task that acted as a control task. The outcome measure shows the movement time.

Outcome measures

Outcome measures
Measure
N-Back Performance During Optimal Stimulation
n=19 Participants
Participants underwent optimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During Suboptimal Stimulation
n=19 Participants
Participants underwent suboptimal stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
N-back Performance During No Stimulation
n=19 Participants
Participants also underwent periods of No Stimulation followed by the N-back task to assess its impact on performance. Accuracy and reaction time were used as performance metrics, with higher accuracy and/or faster responses indicating better performance.
Suboptimal Neuromodulation Day-1
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-1 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-2
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-2 of Suboptimal Stimulation.
Suboptimal Neuromodulation Day-3
n=19 Participants
Participants underwent three consecutive optimal and three consecutive suboptimal neuromodulation sessions in a randomized sequence. The optimal and suboptimal sessions were separated by at least one week to allow the effects of the stimulation to dissipate. This is for Day-3 of Suboptimal Stimulation.
Movement Time Changes in the Reaction Time Index Task Following Optimal vs. Suboptimal rTMS Stimulation
0.411 seconds
Standard Deviation 0.049
0.417 seconds
Standard Deviation 0.087
0.381 seconds
Standard Deviation 0.072
0.411 seconds
Standard Deviation 0.098
0.406 seconds
Standard Deviation 0.074
0.395 seconds
Standard Deviation 0.076

Adverse Events

Optimal rTMS Frequency

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Sub-Optimal rTMS Frequency

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Optimal rTMS Frequency
n=24 participants at risk
Three consecutive days of rTMS using their individualized optimal TMS frequency.
Sub-Optimal rTMS Frequency
n=24 participants at risk
Three consecutive days of rTMS using their individualized sub-optimal TMS frequency.
Nervous system disorders
Headache
8.3%
2/24 • Number of events 4 • Adverse event data was collected from study enrollment until study completion (up to 8 weeks)
0.00%
0/24 • Adverse event data was collected from study enrollment until study completion (up to 8 weeks)
Musculoskeletal and connective tissue disorders
Jaw and Facial Muscle Soreness
0.00%
0/24 • Adverse event data was collected from study enrollment until study completion (up to 8 weeks)
4.2%
1/24 • Number of events 2 • Adverse event data was collected from study enrollment until study completion (up to 8 weeks)
Musculoskeletal and connective tissue disorders
Tear Formation
4.2%
1/24 • Number of events 1 • Adverse event data was collected from study enrollment until study completion (up to 8 weeks)
0.00%
0/24 • Adverse event data was collected from study enrollment until study completion (up to 8 weeks)
Nervous system disorders
Anxiety/Panic/Discomfort
4.2%
1/24 • Number of events 1 • Adverse event data was collected from study enrollment until study completion (up to 8 weeks)
4.2%
1/24 • Number of events 1 • Adverse event data was collected from study enrollment until study completion (up to 8 weeks)

Additional Information

Dr. Desmond Oathes, Principal Investigator

University of Pennsylvania

Phone: 215-573-9390

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place