Clinical trial NCT06960083: Transcranial Magnetic Stimulation in Misophonia
Official title: A Transcranial Magnetic Stimulation Approach to Treat Misophonia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Misophonia
Keywords: Misophonia
Transcranial Magnetic Stimulation
Crossover trial
Single session
EEG
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will undergo two sessions of TMS, one inhibitory and another excitatory. The immediate changes resulting from both will be measured and compared.
Primary purpose: TREATMENT

Brief summary: The purpose of the project is to assess the efficacy of parietal transcranial magnetic stimulation in misophonia. N=60 participants will undergo two transcranial magnetic stimulation sessions: one inhibitory and another excitatory. During both sessions, the parietal region will be stimulated. Participants will perform computerized tasks immediately before and after the stimulation, while EEG, heart rate, and skin temperature will be recorded. These recordings will be used to assess if TMS can be used to improve tolerance to misophonia triggers.


Eligibility criteria: Inclusion Criteria:

* Hypersensitive to presence of a specific sound, which may be accompanied by irritation, anger/outbursts, or fear.
* Must be between the ages of 18 - 55.
* Must be fluent in English since the study's instructions, surveys, and tasks will be in English.

Exclusion Criteria:

* Axis I Psychiatric condition, past or present, as defined in DSM-V.
* Disability or medical condition that prohibits completion of study. Participants must be able to complete all study procedures to ensure optimal conditions for data analysis.
* Central Nervous System (CNS) disease, such as history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological diseases, history of head trauma (defined as loss of consciousness\>3 min), or history of seizures without a resolved etiology. CNS disease and drugs that act in the peripheral or central nervous system are likely to have effects on patterns of neural activity.
* Recent or regular use of psychotropic medication (e.g., amitriptyline for migraines).
* Recent use of drugs of abuse.
* Presence of any mental implants in the head.
* Pregnant or lactating.

Primary outcomes:
measure: Unpleasantness Rating Scale
timeFrame: after each session, 72 hours apart (each session is 2 hours)
Secondary outcomes:
measure: Heart Rate
timeFrame: after each session, 72 hours apart (each session is 2 hours)
measure: Skin Conductance Response
timeFrame: after each session, 72 hours apart (each session is 2 hours)
measure: EEG P1-N1-P2 Complex Peak Amplitude
timeFrame: after each session, 72 hours apart (each session is 2 hours)
measure: EEG P1-N1-P2 Complex Peak Latency
timeFrame: after each session, 72 hours apart (each session is 2 hours)
measure: EEG Frequency Band Amplitude
timeFrame: after each session, 72 hours apart (each session is 2 hours)
measure: EEG Frequency Band Inter-Trial Coherence
timeFrame: after each session, 72 hours apart (each session is 2 hours)
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Parul Jain, PhD
role: PRINCIPAL_INVESTIGATOR
References: