Neurostimulation Versus Therapy for Problems With Emotions

Launched by DUKE UNIVERSITY · Jan 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people manage their emotions better. It combines special brain stimulation, called repetitive transcranial magnetic stimulation (rTMS), with training on how to regulate emotions. The goal is to see how this combined approach affects the brain and behavior, especially compared to just using one of these methods alone. By understanding these effects, researchers hope to find out more about how to personalize emotional support for individuals based on their unique brain responses.

To participate in this study, individuals need to be between 18 and 55 years old and have difficulties with managing emotions, as shown in a specific assessment. They should also have been in a stable form of therapy for the past month. Participants will engage in a one-time session where they will learn emotion regulation skills while receiving brain stimulation. They will have brain scans before and after the session to see any changes, and follow-up visits will occur one week and one month later to check on their progress. It's important to note that this study is not for everyone; those with certain medical conditions or recent changes in therapy may not be eligible.

Gender

ALL

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 lesion, 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, 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)