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

NCT06635967 | Recruiting

• 1 other identifier: 2024098
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

tinnitus; repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (3)

• Tinnitus Handicap Inventory (THI)

  The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

  5 days from baseline

• Tinnitus Handicap Inventory (THI)

  The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

  12 days from baseline

• Tinnitus Handicap Inventory (THI)

  The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

  30 days from baseline

Secondary Outcomes (18)

• Visual Analogue Scale (VAS)

  5 days from baseline

• Visual Analogue Scale (VAS)

  12 days from baseline

• Visual Analogue Scale (VAS)

  30 days from baseline

• Minimum Masking Level (MML)

  5 days from baseline

• Minimum Masking Level (MML)

  12 days from baseline

Study Arms (2)

frequency-specific patterned rTMS

EXPERIMENTAL

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).

Device: frequency-specific rTMS

1 Hz rTMS

ACTIVE COMPARATOR

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).

Device: 1 Hz rTMS

Interventions

frequency-specific rTMS DEVICE

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

frequency-specific patterned rTMS

1 Hz rTMS DEVICE

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

1 Hz rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huawei Li, PhD

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shan Sun, PhD

CONTACT

+86-021-64377134-2033; sunshine7896@126.com

Dongmei Tang, PhD

CONTACT

+86-13023299189; tang.dongm@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 10, 2024
• Study Start: May 21, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-08

Locations

CN (1)