Brain zaps may strengthen emotion control circuits in bipolar disorder

NCT ID NCT06274567

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

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

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

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

24 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Martinos Center for Biomedical Imaging

    RECRUITING

    Charlestown, Massachusetts, 02129, United States

  • University of Pennsylvania, Center for Neuromodulation in Depression and Stress

    RECRUITING

    Philadelphia, Pennsylvania, 19104-4283(215) 573-4229, United States

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