Neurostimulation Versus Therapy for Problems With Emotions

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
• Impulse Control Disorder
• Eating Disorders
• Emotional Dysfunction
• Emotional Instability
• Emotional Distress
• Emotional Maladjustment
• Emotional Impulsivity
• Obsessive-Compulsive Disorder
• Emotion Dysregulation
• Borderline Personality Disorder

Interventions

DEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS)

high frequency rTMS over the right dlPFC

DEVICE

electrical scalp stimulation

electrical scalp stimulation over the right dlPFC

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Andrada D Neacsiu, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-15

Primary Completion

2027-10-31

Completion

2027-12-01

FDA Device

Yes

Countries

• United States

Study Locations