Actively Recruiting
Neurostimulation Versus Therapy for Problems With Emotions
Led by Duke University · Updated on 2026-03-04
240
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.
CONDITIONS
Official Title
Neurostimulation Versus Therapy for Problems With Emotions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 55 years
- Elevated score on the Difficulties with Emotion Regulation Scale (DERS total score 90)
- In the same type of psychotherapy (including none) for the last 4 weeks, except current CBT, and 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 DSM-5 mood, anxiety, stressor, OCD, impulse control, ADHD, or eating disorder (including Bipolar II without current hypomania)
- Verbal agreement to maintain stable dose of prescribed psychotropic medication if stable for past 4 weeks
- Na�ve to repetitive transcranial magnetic stimulation (rTMS)
You will not qualify if you...
- Current hypomania
- Diagnosis or history of psychotic disorder or psychotic features
- Diagnosis of Bipolar I disorder
- Current moderate to severe alcohol or substance use disorder, or past severe alcohol use disorder
- Unable to read, blind, deaf, or unwilling to give consent
- Non-English speaker
- Verbal IQ < 90 on the North American Adult Reading Test (NART)
- Current uncontrolled anorexia or condition requiring hospitalization
- High risk for suicide (attempt in past 6 months or current suicidal ideation with plan, method, or intent)
- Current serious medical illness including severe migraine headaches
- Started or changed psychotropic medications in prior 4 weeks or plans to change during study
- History of seizure (except therapeutic ECT-induced), epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, cranial metal implants, or brain lesions contraindicating TMS
- Devices affected by TMS (pacemaker, medication pump, cochlear implant, brain stimulator)
- Left elbow/hand/wrist tendonitis
- Conditions causing increased intracranial pressure or significant brain lesions unsafe for TMS
- Dementia, Parkinson's, Huntington's, multiple sclerosis
- Use of Wellbutrin >300mg per day or stimulants above FDA recommendations
- Use of investigational drugs or devices within 4 weeks of screening
- Cochlear implants
- Pregnancy
- Metal in body excluding MRI participation or severe claustrophobia
- Prisoner or in police custody or pending court case affecting participation
- Prior TMS treatment
- CBT in past 4 weeks or plans to start therapy during study
- Weight over 300 pounds (cannot fit in MRI scanner)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
Z
Zoe Brasher
CONTACT
L
Lisalynn D Kelley, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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