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| ID | Type | Description | Link |
|---|---|---|---|
| 24-0489-00001 | Other Grant/Funding Number | Misophonia Research Fund |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | The heart rate (number of beats per minute) will be measured using a wristwatch worn by the participant. | after each session, 72 hours apart (each session is 2 hours) |
| Skin Conductance Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shama Patel | Contact | 347-670-4878 | shama.patel@mssm.edu | |
| Parul Jain, PhD | Contact | 212-824-8992 | parul.jain@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Parul Jain, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | Recruiting | New York | New York | 10022 | United States |
All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
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).
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| ID | Term |
|---|---|
| C000719531 | misophonia |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Participants will undergo two sessions of TMS, one inhibitory and another excitatory. The immediate changes resulting from both will be measured and compared.
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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.
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Skin conductance, a measure capturing the amount of sweat, will be measured using a wristwatch worn by the participant.
| after each session, 72 hours apart (each session is 2 hours) |
| EEG P1-N1-P2 Complex Peak Amplitude | Amplitude (microvolts) of P1, N1, and P2 peaks measured in the parietal region | after each session, 72 hours apart (each session is 2 hours) |
| EEG P1-N1-P2 Complex Peak Latency | Latency (milliseconds) of P1, N1, and P2 peaks measured in the parietal region | after each session, 72 hours apart (each session is 2 hours) |
| EEG Frequency Band Amplitude | Amplitude (decibel) in theta (4-8 Hz), alpha (8-13 Hz), and beta (13-30 Hz) frequency bands in the parietal region | after each session, 72 hours apart (each session is 2 hours) |
| EEG Frequency Band Inter-Trial Coherence | Coherence (unitless) across trials in theta (4-8 Hz), alpha (8-13 Hz), and beta (13-30 Hz) frequency bands in the parietal region | after each session, 72 hours apart (each session is 2 hours) |