Comparing two types of magnetic stimulation for chronic tinnitus treatment
The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus
This study is testing whether a new type of magnetic stimulation can help people with chronic tinnitus feel less bothered by their symptoms compared to a standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06635967 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of frequency-specific patterned repetitive transcranial magnetic stimulation (rTMS) compared to 1Hz rTMS in treating chronic subjective tinnitus. It is a single-blind randomized controlled trial where participants will be randomly assigned to receive one of the two types of rTMS. The study will measure tinnitus severity, mood, and sleep quality before, after treatment, and during follow-up. The primary hypothesis is that frequency-specific patterned rTMS will provide greater relief from tinnitus-related distress than the standard 1Hz rTMS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have experienced persistent subjective tinnitus for at least three months.
Not a fit: Patients with conditions such as Meniere's disease, conductive hearing loss, or severe sensorineural hearing loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from chronic tinnitus.
How similar studies have performed: Previous studies have shown promising results for rTMS in treating tinnitus, but the specific comparison of stimulation types in this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults aged between 18 and 80 years old. 2. Experiencing persistant subjective tinnitus for at least 3 months. 3. A score of 38 or more on THI. 4. 50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear. 5. Voluntarily participate in the study and sign the informed consent form. 6. Have normal mental status and cognitive function, and be able to cooperate with the research process. Exclusion Criteria: 1. Diagnosis of Meniere's disease, conductive hearing loss or objective tinnitus. 2. History of epilepsy or stroke. 3. Diagnosis of acoustic neuroma. 4. Severe sensorineural hearing loss. 5. Surgically or traumatically implanted ferromagnetic foreign bodies, including but not limited to pacemakers, neurostimulators, prosthetic metal heart valves, aneurysm clips (non-titanium alloy), intraocular metal foreign bodies, cochlear implants, metal prostheses, metal joints, fixed steel plates or steel pins. 6. Patients with active metal foreign bodies (metal implants, dentures, contraceptive rings), insulin pumps, etc., who have been evaluated in detail and are at risk for rTMS treatment. 7. Patients taking vestibular sedatives, antipsychotics, anxiolytics, antiepileptics, and ototoxic drugs. 8. Patients with a recent history of alcohol or drug abuse 9. Bell's palsy 10. Acute ear infection within the last 1 month 11. Inability to cooperate or complete the study process 12. Participation in another clinical trial within the last month. 13. Have any condition that may affect compliance or safety 14. Any other condition that, in the opinion of the investigator, makes enrollment in the study inappropriate.
Where this trial is running
Shanghai, Shanghai Municipality
- Eye & ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Huawei Li, PhD — Eye and ENT Hospital of Fudan University
- Study coordinator: Shan Sun, PhD
- Email: sunshine7896@126.com
- Phone: +86-021-64377134-2033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.