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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial magnetic stimulation (TMS), a non-invasive brain treatment, can help individuals with misophonia, a condition where certain sounds trigger strong emotional reactions like irritation or anger. Participants will undergo two types of TMS sessions to determine if their response to these sounds changes. The goal is to discover if TMS can ease daily life for those struggling with misophonia triggers. Individuals who are extremely sensitive to specific sounds and often feel angry or fearful because of them might be well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatments for misophonia.

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 prior data suggests that transcranial magnetic stimulation is safe for misophonia?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe and well-tolerated. In past studies, participants mostly reported only mild side effects, such as headaches. The most serious risk is the very rare chance of a seizure. Both types of TMS, which either calm or stimulate brain activity, have also been well-tolerated in other studies. TMS is already used for other conditions, suggesting it is safe when used correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcranial Magnetic Stimulation (TMS) for misophonia because it offers a non-invasive approach that directly targets brain activity. Unlike traditional treatments, which might include cognitive behavioral therapy or medication that can have side effects and require long-term commitment, TMS uses magnetic fields to modulate neural circuits involved in auditory processing and emotional regulation. This technique could potentially provide quicker relief by directly altering the brain's response to sound triggers, offering hope for more immediate and effective symptom management.

What evidence suggests that transcranial magnetic stimulation is effective for misophonia?

This trial will compare two different sequences of transcranial magnetic stimulation (TMS) for misophonia. Research suggests that TMS might help individuals with misophonia, a condition where certain sounds trigger strong emotional reactions. Earlier studies demonstrated that TMS helped participants manage their emotions related to these sounds, as measured by a stress level scale. Although TMS hasn't proven effective for some other conditions, it shows promise for aiding emotional regulation in misophonia. The treatment uses magnetic fields to stimulate specific brain areas, potentially improving sound tolerance. ^{2 3 5 6 7}

Who Is on the Research Team?

Parul Jain, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724001368

An experimental examination of neurostimulation and ... Excitatory rTMS also enhanced the regulation of emotions associated with misophonic sounds in both groups when measured by SUDS (dcontrol = 1.28 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06333925

Study Details | NCT06333925 | Using Neurostimulation to ... The goal in the study is to generate a personalized set of triggers that includes personalized misophonic, aversive and neutral sounds for each participant. The ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2993526/

Is There Evidence for Effectiveness of Transcranial ... TMS has not been shown to be effective in the treatment of obsessive compulsive disorder, posttraumatic disorder, or schizophrenia.

4. trialx.com trialx.com/clinical-trials/listings/291262/using-neurostimulation-to-accelerate-change-in-misophonia-a-pilot-study/

Using Neurostimulation to Accelerate ... The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on ...

5. withpower.com withpower.com/trial/phase-misophonia-4-2025-eecf1

Transcranial Magnetic Stimulation for Misophonia The purpose of the project is to assess the efficacy of parietal transcranial magnetic stimulation in misophonia. N=60 participants will undergo two ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ... Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3260536/

Safety, ethical considerations, and application guidelines for ... There is no safety data on TMS in subjects with cochlear implants, but basic physics considerations suggest that it is likely unsafe. The TMS pulse can induce ...