Recruiting

Neurostimulation vs. Therapy

Sponsor:

Duke University

Code:

NCT05712057

Conditions

Emotion Regulation

Mood Disorders

Stress Disorder

Anxiety Disorders

OCD

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

electrical scalp stimulation

Cognitive Restructuring

Emotional Awareness Training

Study Details

Brief summary:

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

Emotion Regulation

Mood Disorders

Stress Disorder

Anxiety Disorders

OCD

Study ID

NCT05712057

Start date

May 15, 2023

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS)

Group 1 (G1)- 80 eligible participants will receive training in Cognitive Restructuring (CR). These participants will use CR while receiving rTMS over their individual dlPFC target and will partake in short term and long term follow up testing.

active comparator: Cognitive Restructuring + scalp electrical stimulation

Group 2 (G2) - 80 eligible participants will receive training in CR. These participants will use CR while receiving scalp electrical stimulation over their individual dlPFC target and will partake in short term and long term follow up testing.

active comparator: Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS)

Group 3 (G3) - 80 eligible participants will receive emotional awareness training. These participants will receive rTMS over their individual dlPFC target and will partake in short term and long term follow up testing.

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

high frequency rTMS over the right dlPFC

electrical scalp stimulation

electrical scalp stimulation over the right dlPFC

Cognitive Restructuring

Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal.

Emotional Awareness Training

Emotional awareness training is a behavioral intervention through which participants learn how to identify and evaluate their emotions and the components that make up each emotion.

Primary outcome measure

  • High Frequency Heart Rate Variability (HF-HRV) during regulation blocks during the neurostimulation day [ Time Frame: Within a month of the initial assessment ]
  • Time to return to Heart Rate (HR) baseline measured during regulation period [ Time Frame: Within a month of the initial assessment ]
  • Change in the ventrolateral prefrontal cortex (vlPFC) for the [restructure-flow_negative] contrast [ Time Frame: baseline Neuroimaging Scan vs post Neuroimaging scan (1 week follow-up post neurostimulation) ]
  • Change in the dorsomedial prefrontal cortex (dmPFC) for the [restructure-flow_negative] contrast [ Time Frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) ]
  • Change in the ventromedial prefrontal cortex (vmPFC) for the [restructure-flow_negative] contrast [ Time Frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) ]
  • Change in the insular cortex for the [restructure-flow_negative] contrast [ Time Frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) ]
  • Change in dorsolateral prefrontal cortex (dlPFC)-insula connectivity during [restructure - flow_negative] [ Time Frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) ]
  • Change in dorsolateral prefrontal cortex (dlPFC)-amygdala connectivity during [restructure - flow_negative] [ Time Frame: baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) ]

Central Contacts and Locations

Central contacts

Zoe Brasher

9196846785zoe.brasher@duke.edu

Lisalynn D Kelley, CCRP

9196846701lisalynn.kelley@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Andrada D Neacsiu, PhD

919-684-6714andrada.neacsiu@duke.edu

Principal Investigator:

Andrada D Neacsiu, PhD

More Information

Sponsor

Duke University

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • Emotion Dysregulation
  • Distress Intolerance
  • Neuromodulation
  • Neurostimulation
  • TMS
  • cognitive restructuring
  • regulation skills
  • neuroimaging
  • Emotion regulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-04.