Combining neurostimulation with emotion regulation training for emotional issues

Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis

This study is testing if combining brain stimulation with training on how to manage emotions can help people with emotional issues feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Duke University (other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT05712057 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of a one-session training that combines emotion regulation skills training with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex. Participants will be randomly assigned to learn one of two emotion regulation skills while undergoing brain imaging and neurostimulation. The study aims to assess immediate neural and behavioral changes and identify personalized biomarkers for response to the training. The ultimate goal is to develop innovative interventions that leverage neuroscientific findings to improve behavioral treatments for emotional dysregulation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 who experience difficulties with emotion regulation and meet specific diagnostic criteria for mood or anxiety disorders.

Not a fit: Patients with severe anorexia or those not willing to maintain their current psychotherapy regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the effectiveness of treatments for individuals struggling with emotional dysregulation.

How similar studies have performed: While the combination of neurostimulation and emotion regulation training is innovative, similar approaches have shown promise in other studies.

Eligibility criteria

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)

Where this trial is running

Durham, North Carolina

• Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Andrada D Neacsiu, PhD — Duke University
• Study coordinator: Zoe Brasher

Conditions: Emotion Regulation, Mood Disorders, Stress Disorder, Anxiety Disorders, OCD, Impulse Control Disorder, Eating Disorders, Emotional Dysfunction