Brain zaps may supercharge emotion control therapy
NCT ID NCT05712057
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether combining a one-time session of brain stimulation (rTMS or electrical scalp stimulation) with emotion regulation training helps people with mood, anxiety, or related disorders better control their emotions. 240 participants will learn either cognitive restructuring or emotional awareness skills while receiving targeted brain stimulation. Researchers will measure changes in brain activity and emotional responses immediately, at one week, and at one month after the session.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- repetitive transcranial magnetic stimulation (rTMS) and electrical scalp stimulation
- What this could lead to
- If successful, this could point toward a more effective, brain-based approach to help people with emotional dysregulation learn to manage their emotions better.
- What could go wrong
- This is an early-stage study with only one training session, so any benefits may be small or short-lived. The results may not apply to everyone with emotional difficulties.
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 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Dec 2027
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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18 to 55 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: * age 18 to 55 * elevated overall score on Difficulties with Emotion Regulation Scale (DERS total score \>=90) * has been in the same type of psychotherapy (including none) for the last 4 weeks/1mo (\*except for current CBT) and is willing to stay on the same regimen throughout the study. * low self-reported use of cognitive restructuring (ERQ restructuring subscale average score \< 4.7) * meets criteria for at least one mood (including Bipolar II w/o current hypomania), anxiety, stressor, OCD, Impulse Control, ADHD, or eating DSM-5 disorder (except exclusionary diagnoses such as severe anorexia). Note: Both current or partial remission of the disorder will be ok for inclusion into the study. * verbal agreement to maintain dose of prescribed psychotropic medication (if any) constant throughout the study, provided they are stable on it for the past 4 weeks (except exclusion medication and except if there is a medical emergency requiring changes in medication). * Naïve to rTMS Exclusion Criteria: * current hypomania (Note: Bipolar II w/o current hypomanic episode is ok for inclusion) * meets diagnostic criteria for current or history of psychotic disorder, or psychotic features, * meets diagnostic criteria for Bipolar I disorder * meets diagnostic criteria on SCID5 for current alcohol or substance use disorder (moderate and high severity) or meets past history of severe alcohol use disorder * unable to read, blind, or deaf, or unwilling to give consent * non-English speaker, * verbal IQ \< 90 on the North American Adult Reading Test (NART). * current uncontrolled anorexia or other condition requiring hospitalization * high risk for suicide defined as either having attempted suicide in past 6 months or reporting current suicidal ideation that includes a method, plan, or intent to die * current serious medical illness, including current severe migraine headaches * started/changed psychotropic medications in the prior 4 weeks, or plans to change medication during the study * history of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesions that are contraindications for TMS, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator), have left elbow/hand/wrist tendonitis * conditions associated with increased intracranial pressure, space occupying brain lesion (considered significant and unsafe for TMS by the study MD), transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis * Wellbutrin \>300mg per day or on daily stimulant/ADHD medications above the recommended FDA daily recommendations * use of investigational drug or devices within 4 weeks of screening * cochlear implants * Pregnancy * metal in body that would exclude them from the MRI scan; severe claustrophobia * is a prisoner or in police custody at time of screening, or has pending court case jeopardizing the participation in the study * has had TMS in their lifetime * has had CBT in the past 4 weeks or plans to start therapy during the study * weighs over 300 pounds (could not fit in MRI scanner)
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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
1 site. 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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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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