Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study
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.
Conditions:
🦠 Misophonia 🦠 Emotion Dysregulation 🦠 Sensory Processing Disorder 🦠 Auditory Over Responsivity 🦠 Anxiety Disorder 🦠 Sound Sensitivity
🗓️ Study Start (Actual) 14 May 2024
🗓️ Primary Completion (Estimated) 30 November 2026
✅ Study Completion (Estimated) 30 November 2026
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 18-55
    • * 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).
    • * DMQ Impairment score \>= 14

    Exclusion Criteria:

    • * current or past history of mania or psychosis; current hypomania
    • * verbal IQ\< 90 as per the NART
    • * 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)
    • * DMQ Impairment score \< 14
    • * younger than 18 and older than 55
    • * pregnant
    • * 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)
    • * moderate/severe current alcohol or substance use disorder, or past severe alcohol use disorder
    • * unable to read, blind, or deaf, or unwilling to give consent
    • * cannot come to Duke for the in-person study visits
    • * current uncontrolled anorexia or other condition requiring hospitalization
    • * conditions associated with increased intracranial pressure, space occupying brain lesion, transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis
    • * use of investigational drug or devices within 4 weeks of screening
    • * started/changed psychotropic medications or started psychotherapy in the prior 4 weeks, or plans to change medication or stop psychotherapy during the study
Ages Eligible for Study: 18 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 12 February 2024
  • First Submitted that Met QC Criteria 20 March 2024
  • First Posted 27 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 May 2024
  • Last Update Posted 31 May 2024
  • Last Verified May 2024