Brain zaps may strengthen emotion control circuits in bipolar disorder
NCT ID NCT06274567
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study tests whether a non-invasive brain stimulation technique called intermittent theta burst stimulation (iTBS) can strengthen connections between brain regions involved in emotion regulation in people with bipolar disorder. Participants, aged 24 to 65 with bipolar I or II and current depression, receive either real or sham iTBS to a personalized brain target over four days. The researchers measure changes in brain connectivity and performance on emotion-related tasks before and after stimulation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intermittent theta burst stimulation (iTBS) using transcranial magnetic stimulation (TMS)
- What this could lead to
- If successful, this could point toward a non-invasive brain stimulation treatment to help people with bipolar disorder better manage their emotions.
- What could go wrong
- This is an early mechanistic study, not a treatment trial. It may not lead to any clinical benefit, and the effects may be small or temporary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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24 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Individuals of all genders 2. ages 24-65 3. Diagnostic Statistical Manual (DSM-5) defined diagnosis of bipolar I or II disorder (BD); assessed using the Mini-International Neuropsychiatric Interview (M.I.N.I.) version 7.0.2. 4. Current depressive episode, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20, 5. Ability to provide informed consent and verifiable contact information, including current psychiatric treatment provider 6. Stable medication regimen for at least one month, which must include a mood stabilizer Exclusion Criteria: 1. current mania/hypomania assessed by the Young Mania Rating Scale (YMRS \> 12) 2. rapid-cycling bipolar illness, defined as \>4 episodes per year, indicating increased risk of switch to mania 3. current active suicidality (suicidal ideation with intent or plan), as assessed by a score \>4 on the MADRS item #10 4. current substance use disorder for the past 6 months; substance use disorder in remission permitted 5. history of psychosis 6. dementia or other major neurological disorders, as assessed by a Mini-Mental State Exam (MMSE) score \<24 and Montreal Cognitive Assessment (MOCA) score \<26 7. medical illness or non-psychiatric medical treatment that would likely interfere with study participation 8. contraindications for magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS), including the presence of metallic implants that would interfere with safety (i.e. cardiac pacemaker, metal plates, non-removable body piercings, etc.), history of seizure disorder, history of head trauma 9. a clinical course of a neuromodulatory therapy (e.g. transcranial magnetic stimulation, transcranial direct current stimulation, electroconvulsive therapy) within the past 6 months 10. current use of benzodiazepines, which can interfere with iTBS stimulation 11. current pregnancy, to limit potential risks to an unborn child Other: Given that \>86% of BD patients experience lifetime comorbid anxiety, co-occurring anxiety disorders will be allowable for inclusion, thus providing a more representative sample of bipolar patients who typically present at our Clinics for treatment. Comorbid anxiety disorders are not a criteria for inclusion or exclusion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Martinos Center for Biomedical Imaging
RECRUITINGCharlestown, Massachusetts, 02129, United States
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University of Pennsylvania, Center for Neuromodulation in Depression and Stress
RECRUITINGPhiladelphia, Pennsylvania, 19104-4283(215) 573-4229, United States
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