Trial Outcomes & Findings for Task Augmentation of Transcranial Magnetic Stimulation (TMS) (NCT NCT04586205)

Last Updated: 2025-05-31

Results Overview

This Sternberg Sorting Task (SST) task is designed to assess how individuals store and retrieve random information from short-term memory. This task was administered to all participants before they were randomized into one of two groups (active TMS first then sham TMS or sham TMS first then active TMS). 0's were recorded for incorrect responses and 1's were recorded for correct responses. Therefore, the mean represents the accuracy percentage for each group.

Recruitment status

COMPLETED

Target enrollment

17 participants

Primary outcome timeframe

Baseline (Visit 1)

Results posted on

2025-05-31

Participant Flow

There were a total of 17 people consented and completed the SST and emotion task during baseline (Week 1), three people withdrew, only 14 people completed the study, Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. All participants that completed the study, completed the emotional IAPS task high load and low load.

Participant milestones

Participant milestones
Measure	Active Then Sham TMS Randomized Of the 17 Participants to receive active TMS, 8 participants were randomized to active TMS first then received sham TMS after 2 week washout.	Sham TMS vs Active TMS Randomised Of the 17 Participants to receive active TMS, 9 participants were randomized to sham TMS first then received active TMS after 2 week washout.
Baseline With MRI Scan, and SST and IAPS STARTED	8	9
Baseline With MRI Scan, and SST and IAPS Active Then Sham TMS	8	0
Baseline With MRI Scan, and SST and IAPS Sham Then TMS	0	9
Baseline With MRI Scan, and SST and IAPS COMPLETED	7	7
Baseline With MRI Scan, and SST and IAPS NOT COMPLETED	1	2
TMS/Sham Visit, With IAPS STARTED	7	7
TMS/Sham Visit, With IAPS COMPLETED	7	7
TMS/Sham Visit, With IAPS NOT COMPLETED	0	0
Sham/TMS Visit, With IAPS STARTED	7	7
Sham/TMS Visit, With IAPS COMPLETED	7	7
Sham/TMS Visit, With IAPS NOT COMPLETED	0	0
MRI Follow-Up STARTED	7	7
MRI Follow-Up COMPLETED	7	7
MRI Follow-Up NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Then Sham TMS Randomized Of the 17 Participants to receive active TMS, 8 participants were randomized to active TMS first then received sham TMS after 2 week washout.	Sham TMS vs Active TMS Randomised Of the 17 Participants to receive active TMS, 9 participants were randomized to sham TMS first then received active TMS after 2 week washout.
Baseline With MRI Scan, and SST and IAPS Withdrawal by Subject	1	2

Baseline Characteristics

Task Augmentation of Transcranial Magnetic Stimulation (TMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low-load Condition vs High-load n=17 Participants Participants will be assigned to complete either a high-load or a low-load cognition task. They will assigned to for both Sternberg task and emotional task. Sternberg Task: Participants will be randomized to high-load and low-load cognition task in different orders	TMS vs. Task Order Completion Participants will will then complete again (in randomized order) with rTMS: 1. rTMS alone 2. rTMS + SST (cognitive) 3. rTMS + IAPS (emotion) Order of MRI procedures: Participants will be assigned to complete MRI+task, MRI +SST, and MRI + IAPS in random order	Determination of Neuromodulation Effect on DLPFC Activation - Cognitive vs. Emotional Participants will be assigned for the rest of the study to either complete their neuromodulation sessions while either completing the cognitive task, or the emotional task. TMS/Sham TMS: Participants will be randomized to either complete their assigned task (cognitive vs. emotional) while doing sham rTMS vs. real rTMS during weeks 2 and 3 of the study. The order of sham rTMS vs. real rTMS is randomized.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	17 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	34 years STANDARD_DEVIATION 11.25 • n=5 Participants	—	—	34 years STANDARD_DEVIATION 11.25 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	—	—	9 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	—	—	8 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	—	—	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	—	—	2 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	—	—	11 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Region of Enrollment United States	17 participants n=5 Participants	—	—	17 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 1)

Population: There were a total of 17 people that consented, one person that was receiving active TMS first withdrew from the study and two people that were receiving sham TMS first withdrew from the study so only 14 people completed. (seven receiving Active TMS first and seven that were receiving sham TMS first).

Outcome measures

Outcome measures
Measure	Sham Then Active TMS n=9 Participants Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. All participants that completed the study, completed the emotional IAPS task high load and low load. This group is for participants that were randomized to receive sham TMS, and then received active TMS after a two week washout period.	Baseline Measurement Before Active TMS vs Sham TMS n=8 Participants Participants that were randomized to active TMS first then received sham TMS after 2 week washout
Sternberg Sorting Task (SST) at Baseline High-Load SST	0.64 proportion of correct responses Standard Deviation 0.31	0.85 proportion of correct responses Standard Deviation 0.17
Sternberg Sorting Task (SST) at Baseline Low-Load SST	0.66 proportion of correct responses Standard Deviation 0.34	0.87 proportion of correct responses Standard Deviation 0.065

PRIMARY outcome

Timeframe: Baseline

International Affective Picture System (IAPS): an emotional task using IAPS picture that will also compare low load and high load conditions. The number of images will vary by condition load, but for both the high-load \& low-load conditions, participants will look at IAPS pictures and answer questions about the images. Further, jittered within this design will be both neutral and negative blocks of IAPS pictures: Baseline measurement before randomizing participants into Active or Sham groups. 0's were recorded for incorrect responses and 1's were recorded for correct responses. Therefore, the mean represents the accuracy percentage for each group.

Outcome measures

Outcome measures
Measure	Sham Then Active TMS n=9 Participants Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. All participants that completed the study, completed the emotional IAPS task high load and low load. This group is for participants that were randomized to receive sham TMS, and then received active TMS after a two week washout period.	Baseline Measurement Before Active TMS vs Sham TMS n=8 Participants Participants that were randomized to active TMS first then received sham TMS after 2 week washout
International Affective Picture System (IAPS) Low-Load IAPS	0.59 proportion of correct responses Standard Deviation 0.22	0.67 proportion of correct responses Standard Deviation 0.09
International Affective Picture System (IAPS) High-Load IAPS	0.52 proportion of correct responses Standard Deviation 0.14	0.69 proportion of correct responses Standard Deviation 0.21

SECONDARY outcome

Timeframe: post-intervention (Active/Sham) (Week 6 Final Visit)

These measurements were taken at the final visits. For example, the "Active then Sham TMS" group received sham TMS during this outcome measure, and the opposite for "Sham then Active TMS." International Affective Picture System (IAPS): an emotional task using IAPS picture that will also compare low load and high load conditions. The number of images will vary by condition load, but for both the high-load \& low-load conditions, participants will look at IAPS pictures and answer questions about the images. Further, jittered within this design will be both neutral and negative blocks of IAPS pictures. The mean represents the number of correct responses from each group. Values can range from 0-299 for the High-Load IAPS (0 meaning no answers correct, and 299 meaning all answers correct). Values can range from 0-326 for the Low-Load IAPS (0 meaning no answers correct, and 326 meaning all answers correct).

Outcome measures

Outcome measures
Measure	Sham Then Active TMS n=7 Participants Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. All participants that completed the study, completed the emotional IAPS task high load and low load. This group is for participants that were randomized to receive sham TMS, and then received active TMS after a two week washout period.	Baseline Measurement Before Active TMS vs Sham TMS n=7 Participants Participants that were randomized to active TMS first then received sham TMS after 2 week washout
International Affective Picture System (IAPS) at Post-intervention (Active/Sham) High-Load IAPS	121 units on a scale Interval 0.0 to 299.0	178 units on a scale Interval 0.0 to 299.0
International Affective Picture System (IAPS) at Post-intervention (Active/Sham) Low-Load IAPS	223 units on a scale Interval 0.0 to 326.0	193 units on a scale Interval 0.0 to 326.0

SECONDARY outcome

Timeframe: post-intervention (Active/Sham) (Week 6 Final Visit)

In the final visit, we recorded these following tasks in an MRI, in both the group that received active then sham TMS and the group that received sham then active TMS. We are comparing the effects of two distinct cognitive tasks on augmenting the impact of TMS on dorsolateral prefrontal cortex (DLPFC) activity. The first task is the Sternberg task (SST), a working memory task designed to engage cognitive processes by requiring participants to retain and recall information. The second is the International Affective Picture System (IAPS) task, which presents emotionally evocative images to elicit emotional responses. Our goal is to determine which task-cognitive or emotional-more effectively enhances TMS-induced DLPFC activation. Brain activity and connectivity can be quantified on a normalized scale ranging from 0 to 1, where 0 indicates no detectable activity or connectivity, and 1 represents the highest level of activity or connectivity within the measured range.

Outcome measures

Outcome measures
Measure	Sham Then Active TMS n=7 Participants Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. All participants that completed the study, completed the emotional IAPS task high load and low load. This group is for participants that were randomized to receive sham TMS, and then received active TMS after a two week washout period.	Baseline Measurement Before Active TMS vs Sham TMS n=7 Participants Participants that were randomized to active TMS first then received sham TMS after 2 week washout
Comparing the Impact of Sternberg Sort Task (SST), the Working Memory Task and International Affective Picture System (IAPS) Emotional Task on TMS-Induced DLPFC Activation; Post-intervention (Active/Sham) High-Load SST	0.183 score on a scale Interval 0.0 to 1.0	0.266 score on a scale Interval 0.0 to 1.0
Comparing the Impact of Sternberg Sort Task (SST), the Working Memory Task and International Affective Picture System (IAPS) Emotional Task on TMS-Induced DLPFC Activation; Post-intervention (Active/Sham) Low-Load SST	0.056 score on a scale Interval 0.0 to 1.0	0.156 score on a scale Interval 0.0 to 1.0
Comparing the Impact of Sternberg Sort Task (SST), the Working Memory Task and International Affective Picture System (IAPS) Emotional Task on TMS-Induced DLPFC Activation; Post-intervention (Active/Sham) High-Load IAPS	0.135 score on a scale Interval 0.0 to 1.0	0.232 score on a scale Interval 0.0 to 1.0
Comparing the Impact of Sternberg Sort Task (SST), the Working Memory Task and International Affective Picture System (IAPS) Emotional Task on TMS-Induced DLPFC Activation; Post-intervention (Active/Sham) Low-Load IAPS	0.129 score on a scale Interval 0.0 to 1.0	0.201 score on a scale Interval 0.0 to 1.0

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active TMS Then Sham TMS Group: MRI n=8 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 8 participants were randomized to active TMS first then received sham TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. One participant in this group experienced mild pain in the head during the TMS intervention period.	Sham TMS Then Active TMS: MRI n=9 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 9 participants were randomized to sham TMS first then received active TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion.	Active TMS Then Sham TMS Group: Active TMS n=8 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 8 participants were randomized to active TMS first then received sham TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. One participant in this group experienced mild pain in the head during the TMS intervention period.	Sham TMS Then Active TMS: Active TMS n=9 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 9 participants were randomized to sham TMS first then received active TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion.	Active TMS Then Sham TMS Group: Sham TMS n=8 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 8 participants were randomized to active TMS first then received sham TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. One participant in this group experienced mild pain in the head during the TMS intervention period.	Sham TMS Then Active TMS: Sham TMS n=9 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 9 participants were randomized to sham TMS first then received active TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion.	Active TMS Then Sham TMS Group: SST Task n=8 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 8 participants were randomized to active TMS first then received sham TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. One participant in this group experienced mild pain in the head during the TMS intervention period.	Sham TMS Then Active TMS: SST Task n=9 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 9 participants were randomized to sham TMS first then received active TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion.	Active TMS Then Sham TMS Group: IASP Task n=8 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 8 participants were randomized to active TMS first then received sham TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. One participant in this group experienced mild pain in the head during the TMS intervention period.	Sham TMS Then Active TMS: IASP Task n=9 participants at risk Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. 9 participants were randomized to sham TMS first then received active TMS after 2 week washout. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion.
Nervous system disorders Mild Pain in Head	0.00% 0/8 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.	0.00% 0/9 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.	12.5% 1/8 • Number of events 1 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.	0.00% 0/9 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.	0.00% 0/8 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.	0.00% 0/9 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.	0.00% 0/8 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.	0.00% 0/9 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.	0.00% 0/8 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.	0.00% 0/9 • 1 year Each participant took part in both sham TMS and active TMS. They were randomized into which treatment they would receive first. Each participant completed a Baseline visit before being randomized, and all adverse events were recorded from the time the participant signed the consent form until study completion. Adverse events were reported as 2 groups: The group that received active then sham, and the group that received sham then active.

Additional Information

Yvette Sheline

University of Pennsylvania

Phone: 215-573-0082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place