Trial Outcomes & Findings for Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders (NCT NCT03622749)
NCT ID: NCT03622749
Last Updated: 2026-03-03
Results Overview
The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 1: Slope of reaction time during trials with negative valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box
COMPLETED
NA
19 participants
Task administered 10 minutes pre TMS and 5 minutes post TMS
2026-03-03
Participant Flow
Participant milestones
| Measure |
Sham Stimulation First, Then VLPFC Stimulation, Then IPL Stimulation
Participants attended three study visits separated by a minimum of 3 days and a maximum of 10 days. During each study visit, participants completed two behavioral computer tasks, followed by TMS stimulation within 10 minutes of completing computer tasks, followed by repeat completion of computer tasks within 5 minutes of completing stimulation. Visit 1: participants recieved Sham stimulation. Visit 2: Participants received VLPFC stimulation. Visit 3: Participants received IPL stimulation.
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Sham Stimulation First, Then IPL Stimulation, Then VLPFC Stimulation
Participants attended three study visits separated by a minimum of 3 days and a maximum of 10 days. During each study visit, participants completed two behavioral computer tasks, followed by TMS stimulation within 10 minutes of completing computer tasks, followed by repeat completion of computer tasks within 5 minutes of completing stimulation. Visit 1: participants recieved Sham stimulation. Visit 2: Participants received IPL stimulation. Visit 3: Participants received VLPFC stimulation.
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VLPFC Stimulation First, Then Sham Stimulation, Then IPL Stimulation
Participants attended three study visits separated by a minimum of 3 days and a maximum of 10 days. During each study visit, participants completed two behavioral computer tasks, followed by TMS stimulation within 10 minutes of completing computer tasks, followed by repeat completion of computer tasks within 5 minutes of completing stimulation. Visit 1: participants recieved VLPFC stimulation. Visit 2: Participants received Sham stimulation. Visit 3: Participants received IPL stimulation.
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VLPFC, Stimulation First, Then IPL Stimulation, Then Sham Stimulation
Participants attended three study visits separated by a minimum of 3 days and a maximum of 10 days. During each study visit, participants completed two behavioral computer tasks, followed by TMS stimulation within 10 minutes of completing computer tasks, followed by repeat completion of computer tasks within 5 minutes of completing stimulation. Visit 1: participants received VLPFC stimulation. Visit 2: Participants received IPL stimulation. Visit 3: Participants received Sham stimulation.
|
IPL Stimulation First, Then Sham Stimulation, Then VLPFC Stimulation
Participants attended three study visits separated by a minimum of 3 days and a maximum of 10 days. During each study visit, participants completed two behavioral computer tasks, followed by TMS stimulation within 10 minutes of completing computer tasks, followed by repeat completion of computer tasks within 5 minutes of completing stimulation. Visit 1: participants received IPL stimulation. Visit 2: Participants received Sham stimulation. Visit 3: Participants received VLPFC stimulation.
|
IPL Stimulation First, Then VLPFC Stimulation, Then Sham Stimulation
Participants attended three study visits separated by a minimum of 3 days and a maximum of 10 days. During each study visit, participants completed two behavioral computer tasks, followed by TMS stimulation within 10 minutes of completing computer tasks, followed by repeat completion of computer tasks within 5 minutes of completing stimulation. Visit 1: participants received IPL stimulation. Visit 2: Participants received VLPFC stimulation. Visit 3: Participants received Sham stimulation.
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Overall Study
STARTED
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4
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3
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3
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3
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3
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3
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Overall Study
COMPLETED
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4
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3
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3
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2
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3
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3
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Overall Study
NOT COMPLETED
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0
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0
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0
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1
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
Baseline characteristics by cohort
| Measure |
All Participants
n=19 Participants
Demographic information (gender, age, race, ethnicity) was collected from all enrolled participants prior to randomization into experimental study arms/groups.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
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Age, Categorical
Between 18 and 65 years
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19 Participants
n=41 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=41 Participants
|
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Sex: Female, Male
Male
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12 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
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1 Participants
n=41 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: Task administered 10 minutes pre TMS and 5 minutes post TMSPopulation: 3 participants were excluded from the analysis due to greater than 30% missing responses
The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 1: Slope of reaction time during trials with negative valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box
Outcome measures
| Measure |
Sham Pre TMS
n=16 Participants
Performance on behavioral task before Sham (placebo) TMS stimulation
|
Sham Post TMS
n=16 Participants
Performance on behavioral task after Sham (placebo) TMS stimulation
|
IPL Pre TMS
n=16 Participants
Performance on behavioral task before IPL TMS stimulation
|
IPL Post TMS
n=16 Participants
Performance on behavioral task after IPL TMS stimulation
|
VLPFC Pre TMS
n=16 Participants
Performance on behavioral task before VLPFC TMS stimulation
|
VLPFC Post TMS
n=16 Participants
Performance on behavioral task after VLPFC TMS stimulation
|
|---|---|---|---|---|---|---|
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Affective Multisource Interference Task - Reaction Time During Negative Interference Trials
|
733.45 Reaction Time (ms)
Standard Deviation 148.43
|
720.58 Reaction Time (ms)
Standard Deviation 100.31
|
723.09 Reaction Time (ms)
Standard Deviation 86.04
|
698.17 Reaction Time (ms)
Standard Deviation 94.32
|
734.55 Reaction Time (ms)
Standard Deviation 107.43
|
705.65 Reaction Time (ms)
Standard Deviation 114.22
|
PRIMARY outcome
Timeframe: Task administered 10 minutes pre TMS and 5 minutes post TMSPopulation: 3 participants were excluded from analysis due to greater than 30% missing responses
The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 2: Slope of reaction time during trials with positive valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box
Outcome measures
| Measure |
Sham Pre TMS
n=16 Participants
Performance on behavioral task before Sham (placebo) TMS stimulation
|
Sham Post TMS
n=16 Participants
Performance on behavioral task after Sham (placebo) TMS stimulation
|
IPL Pre TMS
n=16 Participants
Performance on behavioral task before IPL TMS stimulation
|
IPL Post TMS
n=16 Participants
Performance on behavioral task after IPL TMS stimulation
|
VLPFC Pre TMS
n=16 Participants
Performance on behavioral task before VLPFC TMS stimulation
|
VLPFC Post TMS
n=16 Participants
Performance on behavioral task after VLPFC TMS stimulation
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|---|---|---|---|---|---|---|
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Affective Multisource Interference Task - Reaction Time During Positive Interference Trials
|
726.68 Reaction Time (ms)
Standard Deviation 136.36
|
735.26 Reaction Time (ms)
Standard Deviation 92.07
|
733.87 Reaction Time (ms)
Standard Deviation 100.09
|
696.09 Reaction Time (ms)
Standard Deviation 88.80
|
730.17 Reaction Time (ms)
Standard Deviation 105.29
|
703.95 Reaction Time (ms)
Standard Deviation 107.30
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PRIMARY outcome
Timeframe: Task administered 10 minutes pre TMS and 5 minutes post TMSPopulation: 3 participants were excluded from analysis due to greater than 30% missing responses
The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 3: Slope of reaction time during trials when the image is of a fearful facial expression but the word is "Happy" (incongruent)
Outcome measures
| Measure |
Sham Pre TMS
n=16 Participants
Performance on behavioral task before Sham (placebo) TMS stimulation
|
Sham Post TMS
n=16 Participants
Performance on behavioral task after Sham (placebo) TMS stimulation
|
IPL Pre TMS
n=16 Participants
Performance on behavioral task before IPL TMS stimulation
|
IPL Post TMS
n=16 Participants
Performance on behavioral task after IPL TMS stimulation
|
VLPFC Pre TMS
n=16 Participants
Performance on behavioral task before VLPFC TMS stimulation
|
VLPFC Post TMS
n=16 Participants
Performance on behavioral task after VLPFC TMS stimulation
|
|---|---|---|---|---|---|---|
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Emotion Conflict Resolution Task - Incongruent Fear Trials Reaction Time
|
699.66 Reaction time (ms)
Standard Error 143.97
|
704.05 Reaction time (ms)
Standard Error 137.59
|
702.21 Reaction time (ms)
Standard Error 126.77
|
684.23 Reaction time (ms)
Standard Error 126.44
|
699.22 Reaction time (ms)
Standard Error 123.86
|
678.50 Reaction time (ms)
Standard Error 129.04
|
PRIMARY outcome
Timeframe: Task administered 10 minutes pre TMS and 5 minutes post TMSPopulation: 3 participants were excluded from analysis due to greater than 30% missing responses
The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 4: Slope of reaction time during trials when the image is of a happy facial expression but the word is "Fear" (incongruent)
Outcome measures
| Measure |
Sham Pre TMS
n=16 Participants
Performance on behavioral task before Sham (placebo) TMS stimulation
|
Sham Post TMS
n=16 Participants
Performance on behavioral task after Sham (placebo) TMS stimulation
|
IPL Pre TMS
n=16 Participants
Performance on behavioral task before IPL TMS stimulation
|
IPL Post TMS
n=16 Participants
Performance on behavioral task after IPL TMS stimulation
|
VLPFC Pre TMS
n=16 Participants
Performance on behavioral task before VLPFC TMS stimulation
|
VLPFC Post TMS
n=16 Participants
Performance on behavioral task after VLPFC TMS stimulation
|
|---|---|---|---|---|---|---|
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Emotion Conflict Resolution Task - Incongruent Happy Trials Reaction Time
|
680.70 Reaction time (ms)
Standard Error 135.55
|
677.77 Reaction time (ms)
Standard Error 132.32
|
685.39 Reaction time (ms)
Standard Error 129.16
|
675.23 Reaction time (ms)
Standard Error 133.21
|
685.34 Reaction time (ms)
Standard Error 125.76
|
674.94 Reaction time (ms)
Standard Error 136.35
|
Adverse Events
All Participants
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