Zapping the brain to tame bipolar mood swings?

NCT ID NCT04284267

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique, could improve emotion regulation in people with bipolar disorder. Fifty-six participants, including healthy controls, underwent brain scans while performing tasks designed to measure emotional control. The goal was to understand how TMS affects brain activity related to emotion regulation, not to provide a treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
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 a small, early-stage study focused on understanding brain activity, not testing a proven treatment. Results may not lead to a direct therapy or apply to all patients.

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

56 people

The number who actually took part.

Started

Mar 2021

Finished

Mar 2026

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

22 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 (Healthy Controls) 1. Male or female age 18-55 2. No history of psychiatric disorder, as assessed using the Mini-International Neuropsychiatric Interview (MINI). 3. Non-Clinical Levels of Emotion Dysregulation, as assessed using the Difficulties in Emotion Regulation Scale (DERS) Non-clinical levels of emotion dysregulation will be defined as a score \< 80 on the DERS. Exclusion Criteria (Healthy Controls) 1. Current or history of psychiatric disorders 2. Endorsement of clinical levels of emotion dysregulation 3. Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol); schizophrenia; delusional disorder; and psychotic disorders. 4. Current pregnancy. 5. Medical illness or non-psychiatric medical treatment that would likely interfere with study participation 6. Neurologic disorder, prior neurosurgical procedure, prior electroconvulsive therapy (ECT) or TMS, history of seizures or head trauma. 7. Presence of metallic implants that would interfere with safety during fMRI scanning. Inclusion Criteria (Bipolar Disorder Group) 1. Male or female age 18-55 2. Diagnosis of Bipolar I Disorder (BD-I), as assessed through MINI. 3. Current mood state euthymic. a. Hamilton-Depression Rating Scale (HAM-D-17) and Young Mania Rating Scale (YMRS) will be used to assess current depressive and manic symptoms. Euthymia will be defined as a HAM-D-17 score \<10 and YMRS score \<12. 4. Clinical Levels of Emotion Dysregulation, as assessed using the DERS. Clinical levels of emotion dysregulation will be defined as a score \> 80 on the DERS. Exclusion Criteria (Bipolar Disorder Group) 1. Current symptoms of mania or depression (YMRS score \>12, HAM-D-17 score \>10). 2. Medication instability (\<3 months). 3. Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol), verified by urine toxicology screen; schizophrenia; delusional disorder; and psychotic disorders. 4. Current pregnancy. 5. Medical illness or non-psychiatric medical treatment that would likely interfere with study participation 6. Neurologic disorder, prior neurosurgical procedure, prior ECT or TMS, history of seizures or head trauma. 7. Presence of metallic implants that would interfere with safety during fMRI scanning.

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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.

Contacts and locations

Locations

  • Martinos Center for Biomedical Imaging

    Charlestown, Massachusetts, 02129, United States

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