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Neurostimulation and Therapy for Emotion Problems

This study is testing different ways to help people who have trouble managing their emotions, including those with mood, stress, or anxiety disorders. Researchers are looking at how combining brain stimulation (repetitive transcranial magnetic stimulation or rTMS, and electrical scalp stimulation) with behavioral therapies (Cognitive Restructuring and Emotional Awareness Training) affects the brain and emotional responses. They want to see if these combinations can improve how people regulate their emotions. To join, you need to be between 18 and 55 years old and have significant difficulties with emotion regulation. The study will measure changes in your heart rate and brain activity to see if the treatments are successful. The study aims to enroll 240 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 240 participants. Participants will be randomly assigned to learn one of two emotion regulation skills.
What's involved
Participants will undergo brain imaging while doing an emotional regulation task. They will also receive a neurostimulation session and a follow-up assessment one week later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to one week after neurostimulation for brain imaging, and within a month for heart rate measurements.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05712057

Neurostimulation Versus Therapy for Problems With Emotions

Recruiting
NAAges 18–55InterventionalTreatment
Duke University
~240 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Repetitive Transcranial Magnetic Stimulation (rTMS)electrical scalp stimulationCognitive RestructuringEmotional Awareness Training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
High Frequency Heart Rate Variability (HF-HRV) during regulation blocks during the neurostimulation day
Measured over Within a month of the initial assessment
+7 more outcomes measured

Conditions

Emotion Regulation
Mood Disorders
Stress Disorder
Anxiety Disorders
OCD
Impulse Control Disorder
Eating Disorders
Emotional Dysfunction
Emotional Instability
Emotional Distress
Emotional Maladjustment
Emotional Impulsivity
Obsessive-Compulsive Disorder
Emotion Dysregulation
Borderline Personality Disorder

Explore related trials

Anxiety DisorderAttention Deficit Hyperactivity DisorderBorderline Personality DisorderEating DisorderImpulse-Control DisorderMood DisorderObsessive Compulsive DisorderStress Disorder

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Andrada D Neacsiu, PhD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Zoe Brasher
[email protected]
9196846785
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
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

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)

What this trial measures

  • High Frequency Heart Rate Variability (HF-HRV) during regulation blocks during the neurostimulation dayWithin a month of the initial assessment

    Calculation of physiological data High frequency HRV (HF-HRV) during regulation blocks during the neurostimulation day accounting for baseline controlling for baseline HF-HRV

  • Time to return to Heart Rate (HR) baseline measured during regulation periodWithin a month of the initial assessment

    Following each negative mood induction during the neurostimulation experiment, the time it takes to return baseline HR will be calculated for each of the three regulation periods.

  • Change in the ventrolateral prefrontal cortex (vlPFC) for the [restructure-flow_negative] contrastbaseline Neuroimaging Scan vs post Neuroimaging scan (1 week follow-up post neurostimulation)

    Change in the maximum activation in the vlPFC from pre-post neuroimaging in the contrast of interest

  • Change in the dorsomedial prefrontal cortex (dmPFC) for the [restructure-flow_negative] contrastbaseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)

    Change in the maximum activation in the dmPFC from pre-post neuroimaging in the contrast of interest

  • Change in the ventromedial prefrontal cortex (vmPFC) for the [restructure-flow_negative] contrastbaseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)

    Change in the maximum activation in the vmPFC from pre-post neuroimaging in the contrast of interest

  • Change in the insular cortex for the [restructure-flow_negative] contrastbaseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)

    Change in the maximum activation in the insula from pre-post neuroimaging in the contrast of interest

  • Change in dorsolateral prefrontal cortex (dlPFC)-insula connectivity during [restructure - flow_negative]baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)

    Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-insula connectivity pre-post neuromaging

  • Change in dorsolateral prefrontal cortex (dlPFC)-amygdala connectivity during [restructure - flow_negative]baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation)

    Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-amygdala connectivity pre-post neuromaging