Transcranial Magnetic Stimulation in Misophonia

NCT06960083 | Recruiting

• 2 other identifiers: STUDY-24-0052724-0489-00001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Misophonia

Keywords

Misophonia; Transcranial Magnetic Stimulation; Crossover trial; Single session; EEG

Outcome Measures

Primary Outcomes (1)

• Unpleasantness Rating Scale

  Participants will be presented with a slider with extremes labelled as extremely unpleasant and extremely pleasant. Ratings will be provided for audio clips and visual cues. Full scale from 0-100, higher score indicates more unpleasantness

  after each session, 72 hours apart (each session is 2 hours)

Secondary Outcomes (6)

• Heart Rate

  after each session, 72 hours apart (each session is 2 hours)

• Skin Conductance Response

  after each session, 72 hours apart (each session is 2 hours)

• EEG P1-N1-P2 Complex Peak Amplitude

  after each session, 72 hours apart (each session is 2 hours)

• EEG P1-N1-P2 Complex Peak Latency

  after each session, 72 hours apart (each session is 2 hours)

• EEG Frequency Band Amplitude

  after each session, 72 hours apart (each session is 2 hours)

Study Arms (2)

Inhibitory-Excitatory (IE) then Excitatory-Inhibitory (EI)

ACTIVE COMPARATOR

Participants in this group will receive an inhibitory TMS in the first session and an excitatory TMS in the second session. The two sessions will be separated by 72 hours.

Other: Transcranial Magnetic Stimulation (TMS)

Excitatory-Inhibitory (EI) then Inhibitory-Excitatory (IE)

ACTIVE COMPARATOR

Participants in this group will receive an excitatory TMS in the first session and an inhibitory TMS in the second session. The two sessions will be separated by 72 hours.

Other: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS) OTHER

Transcranial Magnetic Stimulation (TMS) is an FDA-approved non-invasive brain stimulation technology. It is currently used for treating depression. Applications to other disorders such as OCD and anxiety using TMS are currently under investigation. TMS will be administered for 25 minutes.

Excitatory-Inhibitory (EI) then Inhibitory-Excitatory (IE); Inhibitory-Excitatory (IE) then Excitatory-Inhibitory (EI)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Epilepsy or previous episode of convulsion or seizure.
• Previous episode of fainting spell or syncope.
• Head trauma.
• Hearing problems.
• Cochlear implant.
• Metal in the brain, skull, or anywhere else in the body (e.g., splinters, fragments, clips, etc.).
• Implanted neurostimulator (e.g., DBS, epidural/subdural, VNS).
• Presence of cardiac pacemaker or intracardiac lines.
• Presence of medication infusion device.
• Use of pro-convulsant or epileptogenic medications.
• Pregnancy. The risks associated with TMS exposure during gestation have not been studied extensively. We wish to safeguard the health of potential participants and their children.
• Lactation. The risks associated with TMS during lactation and its effects on infant development have not been studied. We wish to safeguard the health of potential participants and their children.
• Presence of Mania, Psychosis, Antisocial Personality Disorder, Borderline Personality Disorder, and Suicidal Ideation.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Conditions

misophonia

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Parul Jain, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shama Patel

CONTACT

347-670-4878; shama.patel@mssm.edu

Parul Jain, PhD

CONTACT

212-824-8992; parul.jain@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a TMS study. Only the technician administering TMS will be unblinded. All parties will be blinded till the end of the study. The technician is not involved in the data analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Model Details: Participants will undergo two sessions of TMS, one inhibitory and another excitatory. The immediate changes resulting from both will be measured and compared.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 7, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to parul.jain@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (to be determined).

Locations

US (1)