Transcranial Magnetic Stimulation for Misophonia

Overseen By Shama Patel

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Psychotropic drugs, drugs of abuse

Disqualifiers: Axis I psychiatric condition, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants do not use psychotropic medications (drugs that affect the mind) recently or regularly. If you are taking such medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for Misophonia?

Research shows that repetitive transcranial magnetic stimulation (rTMS) has been used to reduce symptoms in conditions like tinnitus, which involves abnormal sensory processing similar to misophonia. This suggests that rTMS might help with misophonia by altering brain activity related to sensory processing. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) generally safe for humans?

TMS is generally considered safe and well-tolerated, with the most serious risk being a rare occurrence of seizures. Common mild side effects include headache, nausea, and discomfort at the stimulation site, but these are usually manageable. ^{6 7 8 9 10}

How does the treatment Transcranial Magnetic Stimulation differ from other treatments for misophonia?

Transcranial Magnetic Stimulation (TMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain, which is different from typical drug-based treatments. It has been used successfully for various psychiatric and neurological conditions, offering a novel approach for conditions like misophonia where standard treatments may not exist. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Parul Jain, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for individuals with misophonia, a condition where certain sounds trigger emotional or physiological responses. Participants must be eligible to undergo Transcranial Magnetic Stimulation (TMS) and willing to complete computerized tasks while being monitored via EEG, heart rate, and skin temperature.

Inclusion Criteria

Must be fluent in English since the study's instructions, surveys, and tasks will be in English

Hypersensitive to presence of a specific sound, which may be accompanied by irritation, anger/outbursts, or fear

Exclusion Criteria

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

Axis I Psychiatric condition, past or present, as defined in DSM-V

I use medication for mental health or migraines.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo two transcranial magnetic stimulation sessions: one inhibitory and another excitatory, with sessions separated by 72 hours

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study tests if TMS can help people with misophonia by using two types of stimulation on the parietal region: one inhibitory and one excitatory. Each participant will experience both sessions to see if there's an improvement in their tolerance to triggers.

Participant Groups

Group I: Inhibitory-Excitatory (IE) then Excitatory-Inhibitory (EI) Active Control 1 Intervention

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.

Group II: Excitatory-Inhibitory (EI) then Inhibitory-Excitatory (IE) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

A systematic review of 106 studies involving 1815 patients showed that repetitive transcranial magnetic stimulation (rTMS) is generally safe, with mild adverse events occurring in 16.7% of subjects.

The most serious adverse event was seizure, with a very low risk of 0.16%, while aggravation of sensory phenomena occurred in 1.54% of cases, indicating that while rTMS is well-tolerated, further research is needed to systematically assess safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repetitive transcranial magnetic stimulation in patients with pathologic positive sensory phenomena: a review of literature. Muller, PA., Pascual-Leone, A., Rotenberg, A.[2021]

In a case study involving a single patient, maintenance sessions of low-frequency repetitive transcranial magnetic stimulation (1 Hz rTMS) successfully reduced tinnitus loudness to a visual analogue rating (VAR) of 6 or lower, demonstrating its feasibility for managing chronic tinnitus.

The treatment was well tolerated with no side effects, and tinnitus remained unobtrusive in daily life for four months after the final maintenance session, suggesting potential long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance repetitive transcranial magnetic stimulation can inhibit the return of tinnitus. Mennemeier, M., Chelette, KC., Myhill, J., et al.[2021]

Mild adverse effects (MAEs) from transcranial magnetic stimulation (TMS) occur in about 5% of sessions, with most symptoms like headache and nausea reported after the sessions, particularly during initial treatments.

The study found no significant links between participant characteristics (age and gender) or TMS parameters (frequency and intensity) and the occurrence of MAEs, suggesting that initial participant anxiety may play a role in these reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. Maizey, L., Allen, CP., Dervinis, M., et al.[2022]

Transcranial magnetic stimulation (TMS) is an FDA-approved, noninvasive treatment for major depressive disorder, with response rates of 40%-60% in treatment-resistant cases, indicating its efficacy in improving mood and brain function.

TMS is generally safe and well tolerated, with the rarest serious risk being seizure, making it a low-risk option for patients seeking alternatives to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric Applications of Repetitive Transcranial Magnetic Stimulation. Marder, KG., Barbour, T., Ferber, S., et al.[2023]

Transcranial magnetic stimulation (TMS) has been shown to have a very low incidence of side effects, with the most serious being seizures, which often occurred when stimulation parameters were not followed or when combined with medications that lower seizure thresholds.

The expert consensus indicates that repetitive TMS (rTMS) is effective for treating chronic neuropathic pain, major depressive episodes, and auditory hallucinations, suggesting it has a strong therapeutic indication in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[French guidelines on the use of repetitive transcranial magnetic stimulation (rTMS): safety and therapeutic indications]. Lefaucheur, JP., André-Obadia, N., Poulet, E., et al.[2022]

Transcranial magnetic stimulation (TMS) is a safe and effective treatment approved for conditions like treatment-resistant major depressive disorder and obsessive-compulsive disorder, which are common and significantly impact public health.

Despite its effectiveness, many healthcare providers are not familiar with TMS, highlighting the need for better education on its use and benefits, especially for patients with chronic conditions resistant to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation: A Clinical Primer for Nonexperts. Minzenberg, MJ., Yoon, JH.[2021]

High-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the primary motor cortex is definitively effective for pain relief, while high-frequency rTMS targeting the left dorsolateral prefrontal cortex is effective for treating depression, based on a review of evidence up to March 2014.

Low-frequency rTMS of the right dorsolateral prefrontal cortex shows probable efficacy for depression, and high-frequency rTMS of the left dorsolateral prefrontal cortex may help with negative symptoms of schizophrenia, indicating that rTMS can be a valuable treatment option for various mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Lefaucheur, JP., André-Obadia, N., Antal, A., et al.[2022]

Transcranial magnetic stimulation (TMS) is a non-invasive and painless method used since 1985 to stimulate the brain and cranial nerves, with applications in both diagnostics and treatment.

Repetitive TMS can modify the excitability of the cerebral cortex, making it a promising therapeutic tool for investigating neural circuitry and treating various neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in clinical practice. Alisauskiene, M., Truffert, A., Vaiciene, N., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repetitive transcranial magnetic stimulation in patients with pathologic positive sensory phenomena: a review of literature. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Short term effects of repetitive transcranial magnetic stimulation in patients with catastrophic intractable tinnitus: preliminary report. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Maintenance repetitive transcranial magnetic stimulation can inhibit the return of tinnitus. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of repetitive transcranial magnetic stimulation in unilateral tinnitus. [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Individualized Repetitive Transcranial Magnetic Stimulation Treatment in Chronic Tinnitus? [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Psychiatric Applications of Repetitive Transcranial Magnetic Stimulation. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Pain during transcranial magnetic stimulation in youth. [2021]

9. France pubmed.ncbi.nlm.nih.gov

[French guidelines on the use of repetitive transcranial magnetic stimulation (rTMS): safety and therapeutic indications]. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation: A Clinical Primer for Nonexperts. [2021]

11. Spain pubmed.ncbi.nlm.nih.gov

[Transcranial magnetic stimulation. Clinical trials in psychiatry: therapeutical use]. [2009]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). [2022]

13. England pubmed.ncbi.nlm.nih.gov

Dissociable modulating effect of repetitive transcranial magnetic stimulation on sensory and pain perception. [2019]

14. Ireland pubmed.ncbi.nlm.nih.gov

Modification of rectal function and emotion by repetitive transcranial magnetic stimulation in humans. [2021]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in clinical practice. [2018]