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Device

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week follow-up after neurostimulation, 1- and 3-month follow-up for reporting.

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 more

Secondary 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 more

Awards & 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

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