RecruitingNot ApplicableNCT06635967

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


Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

120 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • Adults aged between 18 and 80 years old.
  • Experiencing persistant subjective tinnitus for at least 3 months.
  • A score of 38 or more on THI.
  • 50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
  • Voluntarily participate in the study and sign the informed consent form.
  • Have normal mental status and cognitive function, and be able to cooperate with the research process.

Exclusion Criteria14

  • Diagnosis of Meniere's disease, conductive hearing loss or objective tinnitus.
  • History of epilepsy or stroke.
  • Diagnosis of acoustic neuroma.
  • Severe sensorineural hearing loss.
  • 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.
  • 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.
  • Patients taking vestibular sedatives, antipsychotics, anxiolytics, antiepileptics, and ototoxic drugs.
  • Patients with a recent history of alcohol or drug abuse
  • Bell's palsy
  • Acute ear infection within the last 1 month
  • Inability to cooperate or complete the study process
  • Participation in another clinical trial within the last month.
  • Have any condition that may affect compliance or safety
  • Any other condition that, in the opinion of the investigator, makes enrollment in the study inappropriate.

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Interventions

DEVICEfrequency-specific rTMS

Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals

DEVICE1 Hz rTMS

Low-frequency rTMS will be performed at a frequency of 1Hz


Locations(1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT06635967


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