Neurostimulation Versus Therapy for Problems With Emotions

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05712057
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) — DEVICE
    high frequency rTMS over the right dlPFC
  • electrical scalp stimulation — DEVICE
    electrical scalp stimulation over the right dlPFC
  • Cognitive Restructuring — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 15, 2023
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Andrada D Neacsiu, PhD
[email protected]
919-684-6714
Andrada D Neacsiu, PhD (PRINCIPAL_INVESTIGATOR)
Noreen Bukhari-Parlakturk, MD (SUB_INVESTIGATOR)
Kevin LaBar, PhD (SUB_INVESTIGATOR)

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By research site
Duke University Medical Center· Durham, NC

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