The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus

Last updated: October 9, 2024
Sponsor: Eye & ENT Hospital of Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tinnitus

Treatment

1 Hz rTMS

frequency-specific rTMS

Clinical Study ID

NCT06635967
2024098
  • Ages 18-80
  • All Genders

Study 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

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 theresearch process.

Exclusion

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 butnot limited to pacemakers, neurostimulators, prosthetic metal heart valves, aneurysmclips (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, contraceptiverings), insulin pumps, etc., who have been evaluated in detail and are at risk forrTMS 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 inthe study inappropriate.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: 1 Hz rTMS
Phase:
Study Start date:
May 21, 2024
Estimated Completion Date:
December 30, 2025

Study Description

Tinnitus is a common disorder with a prevalence of 10-25% among adults, which seriously affects the quality of life of patients. Many studies have reported significant efficacy of repetitive transcranial magnetic stimulation (rTMS) for tinnitus, but its optimal stimulation parameters are not clear. Therefore, there is necessary to assess the clinical efficacy and mechanism of different types of rTMS for the treatment of chronic subjective tinnitus through rigorously designed clinical studies.

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.

Connect with a study center

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai 200031
    China

    Active - Recruiting

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