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Not Yet Recruiting NCT05712057

Neurostimulation Versus Therapy for Problems With Emotions

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

Sex: All
Ages: 18 Years – 55 Years
Phase: NA
Enrollment: 240
Sponsor: Duke University

Location: United States

Summary

The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining cognitive restructuring (CR), an emotion regulation skill, 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 participate in brain imaging while undergoing an emotional regulation task. Participants will be randomly assigned to CR training or to psychoeducation about emotions. Participants will be reminded of recent stressors and will undergo real or sham high frequency rTMS, targeted using fMRI (functional MRI) results. Participants who learned CR will practice this skill during rTMS 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.

Eligibility Criteria

Inclusion Criteria:age 18 to 55elevated 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 rTMSExclusion 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 disordermeets diagnostic criteria on SCID5 for current alcohol or substance use disorder (moderate and high severity) or meets past history of severe alcohol use disorderunable to read, blind, or deaf, or unwilling to give consentnon-English speaker,verbal IQ < 90 on the North American Adult Reading Test (NART).current uncontrolled anorexia or other condition requiring hospitalizationhigh 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 diecurrent serious medical illness, including current severe migraine headachesstarted/changed psychotropic medications in the prior 4 weeks, or plans to change medication during the studyhistory 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)conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosison medications that reduce seizure threshold (e.g., stimulants, Wellbutrin, Clozaril, Provigil)use of investigational drug or devices within 4 weeks of screeningcochlear implantsPregnancymetal in body that would exclude them from the MRI scan; severe claustrophobiais a prisoner or in police custody at time of screening, or has pending court case jeopardizing the participation in the studyhas had TMS in their lifetimehas had CBT in the past 4 weeks or plans to start therapy during the studyweighs over 300 pounds (could not fit in MRI scanner)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05712057). StuddyBuddy aggregates publicly available trial information.