Combining neurostimulation with emotion regulation training for emotional issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Duke University Medical Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Andrada D Neacsiu, PhD — Duke University
• Study coordinator: Zoe Brasher
• Email: zoe.brasher@duke.edu
• Phone: 9196846785

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.