NCT06635967 The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus
| NCT ID | NCT06635967 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-05-21 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to compare the efficacy of frequency-specific patterned repetitive transcranial magnetic stimulation (rTMS) and 1Hz rTMS for the treatment of chronic subjective tinnitus. In this single-blind randomized controlled study, patients will be randomly assigned 1:1 to receive two different types of rTMS stimulation.
Eligibility 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.
Contact & Investigator
Huawei Li, PhD
PRINCIPAL INVESTIGATOR
Eye and ENT Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06635967 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Tinnitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06635967 currently recruiting?
Yes, NCT06635967 is actively recruiting participants. Contact the research team at sunshine7896@126.com for enrollment information.
Where is the NCT06635967 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06635967 clinical trial?
NCT06635967 is sponsored by Eye & ENT Hospital of Fudan University. The principal investigator is Huawei Li, PhD at Eye and ENT Hospital of Fudan University. The trial plans to enroll 120 participants.