RecruitingNot ApplicableNCT06333925

Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study


Sponsor

Duke University

Enrollment

60 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing whether a type of non-invasive brain stimulation (TMS — transcranial magnetic stimulation) can speed up improvement in people with misophonia, a condition where certain everyday sounds trigger intense anger, anxiety, or distress. **You may be eligible if...** - You are between 18 and 55 years old - You have misophonia that significantly impairs your daily functioning (scoring 14 or higher on a standard misophonia scale) - If you take psychiatric medications, you have been on a stable dose for at least 4 weeks **You may NOT be eligible if...** - You have a current or past history of mania, psychosis, or current hypomania - You have a verbal IQ below 90 - You take medications that lower the seizure threshold (such as lithium, Wellbutrin, stimulants, Clozaril, or similar drugs) - You are not medically cleared for TMS or brain MRI - Your misophonia impairment score is below 14 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS)

10 Hz rTMS over the right dorsal lateral prefrontal cortex (dlPFC)

DEVICESham Repetitive Transcranial Magnetic Stimulation (sham- rTMS)

inactive rTMS over the right dorsolateral prefrontal cortex (dlPFC)

BEHAVIORALCognitive Restructuring

Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about misophonic sound triggers in order to feel less emotional arousal.


Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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NCT06333925


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