Clinical trial NCT06635967: The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus
Official title: The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
repetitive transcranial magnetic stimulation
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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.

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 5 days from baseline
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 12 days from baseline
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 30 days from baseline
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 5 days from baseline
measure: Visual Analogue Scale (VAS)
timeFrame: 12 days from baseline
measure: Visual Analogue Scale (VAS)
timeFrame: 30 days from baseline
measure: Minimum Masking Level (MML)
timeFrame: 5 days from baseline
measure: Minimum Masking Level (MML)
timeFrame: 12 days from baseline
measure: Minimum Masking Level (MML)
timeFrame: 30 days from baseline
measure: Tinnitus Loudness Matching (LM)
timeFrame: 5 days from baseline
measure: Tinnitus Loudness Matching (LM)
timeFrame: 12 days from baseline
measure: Tinnitus Loudness Matching (LM)
timeFrame: 30 days from baseline
measure: Duration and intensity of residual inhibition (RI) for tinnitus
timeFrame: 5 days from baseline
measure: Duration and intensity of residual inhibition (RI) for tinnitus
timeFrame: 12 days from baseline
measure: Duration and intensity of residual inhibition (RI) for tinnitus
timeFrame: 30 days from baseline
measure: Self-rating Anxiety Scale (SAS)
timeFrame: 5 days from baseline
measure: Self-rating Anxiety Scale (SAS)
timeFrame: 12 days from baseline
measure: Self-rating Anxiety Scale (SAS)
timeFrame: 30 days from baseline
measure: Athens Insomnia Scale (AIS)
timeFrame: 5 days from baseline
measure: Athens Insomnia Scale (AIS)
timeFrame: 12 days from baseline
measure: Athens Insomnia Scale (AIS)
timeFrame: 30 days from baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Huawei Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: