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Neurostimulation for Misophonia (MISO-STIM Trial)
N/A
Recruiting
Led By Andrada D Neacsiu, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week follow-up after neurostimulation, 1- and 3-month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study a new intervention for misophonia, a condition where certain repetitive sounds cause distress. The intervention involves using emotion regulation strategies and brain stimulation to reduce misophonic distress. The
Who is the study for?
This trial is for adults with moderate to severe misophonia, which makes them highly sensitive to certain sounds. Participants should be able to attend 9-10 visits including MRI scans and follow-up sessions. Details on specific inclusion and exclusion criteria are not provided.
What is being tested?
The study tests a new intervention combining emotion regulation strategies with brain stimulation (HF rTMS or sham-rTMS) over four sessions, aiming to reduce distress from misophonia by targeting the brain's emotion regulation areas.
What are the potential side effects?
Potential side effects of HF rTMS may include discomfort at the stimulation site, headache, lightheadedness, seizures (rare), or hearing loss if adequate ear protection isn't used during treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 week follow-up after neurostimulation, 1- and 3-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week follow-up after neurostimulation, 1- and 3-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Subjective Unites of Distress (SUDS)
Change in misophonia impairment and severity using a composite
Differential change in BOLD signal connectivity between the left Anterior Insular Cortex (AIC) and the right dorsolateral prefrontal cortex (dlPFC) when downregulating versus experiencing distress related to misophonic trigger sounds
+4 moreSecondary study objectives
Changes in clinician-assessed psychopathology
Changes in self-reported psychopathology
Emotional dysregulation as measured by the Difficulties in Emotion Regulation Scale (DERS)
Other study objectives
Baseline Affect Intensity
Baseline emotional dysregulation
Baseline hyperacusis
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Restructuring + High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)Experimental Treatment2 Interventions
30 eligible participants will receive training in Cognitive Restructuring (CR). These participants will use CR while being exposed to misophonic trigger sounds and also receiving high frequency rTMS over their personalized right dorsal lateral prefrontal cortex (dlPFC) target. These participants will partake in short term and long term follow-up testing.
Group II: Cognitive Restructuring + Shame Repetitive Transcranial Magnetic Stimulation (rTMS)Active Control2 Interventions
30 eligible participants will receive training in Cognitive Restructuring (CR). These participants will use CR while being exposed to misophonic trigger sounds and also receiving placebo rTMS over their personalized right dorsal lateral prefrontal cortex (dlPFC) target. These participants will partake in short term and long term follow-up testing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Restructuring
2016
Completed Phase 1
~990
Find a Location
Who is running the clinical trial?
Misophonia Research FundUNKNOWN
1 Previous Clinical Trials
59 Total Patients Enrolled
Duke UniversityLead Sponsor
2,462 Previous Clinical Trials
2,968,860 Total Patients Enrolled
11 Trials studying Anxiety Disorders
2,778 Patients Enrolled for Anxiety Disorders
Andrada D Neacsiu, PhDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
447 Total Patients Enrolled
1 Trials studying Anxiety Disorders
240 Patients Enrolled for Anxiety Disorders