The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus
NCT ID: NCT06635967
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-05-21
2025-12-30
Brief Summary
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Detailed Description
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The study will assess the severity of tinnitus and the mood and sleep status of the patients through several scales and tinnitus psychoacoustic assessment before treatment, after treatment and at follow-up. The primary research hypothesis is that frequency-specific patterned rTMS will be superior to 1Hz rTMS in reducing tinnitus-related distress.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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frequency-specific patterned rTMS
Patients will receive a 5-day, once-daily frequency-specific patterned rTMS treatment via a circular coil applied to the auditory cortex. Each session will last 40 minutes and will be stimulated at an intensity of 80% resting motor threshold (RMT).
frequency-specific rTMS
Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals
1 Hz rTMS
Patients will receive a 5-day, once-daily 1Hz rTMS treatment via a circular coil applied to the auditory cortex. Each session will last 40 minutes and will be stimulated at an intensity of 80% resting motor threshold (RMT).
1 Hz rTMS
Low-frequency rTMS will be performed at a frequency of 1Hz
Interventions
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frequency-specific rTMS
Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals
1 Hz rTMS
Low-frequency rTMS will be performed at a frequency of 1Hz
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Huawei Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Eye and ENT Hospital of Fudan University
Locations
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Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024098
Identifier Type: -
Identifier Source: org_study_id
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