RECRUITING

Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on misophonic distress. This study will examine changes in brain activity during presentation and regulation of misophonic versus distressing sounds. The study team plans to alter activity in a key area of the brain responsible for emotion regulation circuitry over 4 sessions with the goal to test if this intervention helps misophonic distress. Sixty adult participants with moderate to severe misophonia will be recruited and taught an emotion regulation skill and randomly assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS). The study includes 9-10 visits: the remote screening visit(s), the initial MRI, the four neurostimulation sessions, the follow-up MRI, and two additional remote 1- and 3-month follow-up visits.

Official Title

Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study

Quick Facts

Study Start:2024-05-14
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06333925

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-55
  2. * verbal agreement to maintain dose of prescribed psychotropic medication (if any) and/or psychotherapy (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).
  3. * DMQ Impairment score \>= 14
  1. * current or past history of mania or psychosis; current hypomania
  2. * verbal IQ\< 90 as per the NART
  3. * not medically cleared for TMS or fMRI (such as taking medications known to reduce the seizure threshold such as Lithium, Clozaril, stimulants including the ADHD medications (e.g. Ritalin, Adderall), Wellbutrin/Buproprion, Provigil (Modafinil), Aminophylline, and Theophylline)
  4. * DMQ Impairment score \< 14
  5. * younger than 18 and older than 55
  6. * pregnant
  7. * high risk for suicide (defined as having attempted suicide in past 6 months; suicide attempt within the past 10 years with current ideation with plan or preferred method available)
  8. * moderate/severe current alcohol or substance use disorder, or past severe alcohol use disorder
  9. * unable to read, blind, or deaf, or unwilling to give consent
  10. * cannot come to Duke for the in-person study visits
  11. * current uncontrolled anorexia or other condition requiring hospitalization
  12. * conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis
  13. * use of investigational drug or devices within 4 weeks of screening
  14. * started/changed psychotropic medications or started psychotherapy in the prior 4 weeks, or plans to change medication or stop psychotherapy during the study

Contacts and Locations

Study Contact

Jessica Choi, MA
CONTACT
919-684-4432
jessica.choi@duke.edu
Lisalynn D Kelley, BA, CCRP
CONTACT
919-684-6701
lisalynn.kelley@duke.edu

Principal Investigator

Andrada D Neacsiu, PhD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Andrada D Neacsiu, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-14
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2024-05-14
Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

  • Neurostimulation
  • Cognitive Restructuring
  • Sound Sensitivity
  • Neuroscience
  • Neuroimaging
  • Neuromodulation
  • Misophonia
  • Emotion Dysregulation
  • Emotion Regulation Skills
  • Repetitive Transmagnetic Stimulation
  • TMS
  • Emotion Regulation

Additional Relevant MeSH Terms

  • Misophonia
  • Emotion Dysregulation
  • Sensory Processing Disorder
  • Auditory Over Responsivity
  • Anxiety Disorder
  • Sound Sensitivity