Trial results for a pilot study investigating neuromodulation for emotion regulation in Bipolar Disorder were posted on ClinicalTrials.gov on 2026-03-03. The study, involving 19 participants, showed significant reductions in reaction times, suggesting improved emotion regulation.
Background
Bipolar disorder is a mental health condition characterized by extreme mood swings. This research study aimed to better understand how individuals with bipolar disorder regulate their emotions. The investigators also sought to determine if transcranial magnetic stimulation (TMS), a technique involving magnetic fields to stimulate nerve cells in the brain, could help improve emotion regulation for these individuals.
Trial design
This pilot study enrolled 19 participants. The trial investigated Bipolar Disorder and the application of Transcranial Magnetic Stimulation. The study's objective was to understand emotion regulation in individuals with bipolar disorder and explore if TMS could improve it. The trial design involved comparing reaction times before and after TMS across different stimulation sites (IPL, VLPFC) and a sham condition. The phase of the trial was not specified (NA).
Key results
The study reported on several key measurements related to reaction time in an Affective Multisource Interference Task:
- Affective Multisource Interference Task - Reaction Time During Negative Interference Trials:
- Sham Pre TMS: Mean 733.45 ms (Standard Deviation 148.43)
- Sham Post TMS: Mean 720.58 ms (Standard Deviation 100.31)
- IPL Pre TMS: Mean 723.09 ms (Standard Deviation 86.04)
- IPL Post TMS: Mean 698.17 ms (Standard Deviation 94.32)
- VLPFC Pre TMS: Mean 734.55 ms (Standard Deviation 107.43)
- VLPFC Post TMS: Mean 705.65 ms (Standard Deviation 114.22)
- Affective Multisource Interference Task - Reaction Time During Positive Interference Trials:
- Sham Pre TMS: Mean 726.68 ms (Standard Deviation 136.36)
- Sham Post TMS: Mean 735.26 ms (Standard Deviation 92.07)
- IPL Pre TMS: Mean 733.87 ms (Standard Deviation 100.09)
- IPL Post TMS: Mean 696.09 ms (Standard Deviation 88.80)
- VLPFC Pre TMS: Mean 730.17 ms (Standard Deviation 105.29)
- VLPFC Post TMS: Mean 703.95 ms (Standard Deviation 107.30)
Key analyses using Mixed Models Analysis, computing the slope of trial by trial reaction time differences (Time x Target Interaction), reported the following:
- A slope of -22.64 with a p-value of 0.0001.
- A slope of -17.78 with a p-value of 0.01.
- A slope of -4.86 with a p-value of 0.02.
- A slope of -36.62 with a p-value of 0.0002.
- A slope of -37.43 with a p-value of 0.002.
- A slope of -2.872 with a p-value of 0.33.
What this means
The results from this pilot study suggest that transcranial magnetic stimulation (TMS) may have a positive impact on emotion regulation in individuals with Bipolar Disorder. The observed reductions in reaction times, particularly the statistically significant negative slopes from the mixed models analyses (e.g., p-value of 0.0001 for a slope of -22.64), indicate an improvement in performance on the Affective Multisource Interference Task. This exploratory finding warrants further investigation into TMS as a potential therapeutic approach for enhancing emotion regulation in this patient population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03622749, titled "Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders", were posted on 2026-03-03 on clinicaltrials.gov.