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Research on Transcranial Electrical Stimulation Therapy for Tinnitus

Research on the reorganization mechanism of the auditory-limbic system in tinnitus and efficacy prediction via a-tACS based on 5.0T MRI multimodal coupling

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094914
Enrollment
Unknown
Registered
2024-12-30
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic tinnitus

Interventions

Intervention Group of Patients with Idiopathic Tinnitus:individualized alpha frequency transcranial electrical stimulation therapy
Non-intervention Group of Patients with Idiopathic Tinnitus:sham individualized alpha-band tACS
Healthy Controls:Non

Sponsors

Beijing Friendship Hospital ,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Tinnitus Patients: 1) Patients with idiopathic tinnitus, aged 18-75 years; 2) with a medical history of more than 6 months; 3) able to cooperate with auditory function tests and psychoacoustic tests; 4) with tinnitus main frequency between 125 and 8000Hz; 5) volunteers who have signed the informed consent form and are willing to participate in this study, and can cooperate with daily device treatment; 6) willing and able to undergo regular follow-up examinations; 7) with sufficient Chinese reading and writing skills to understand and complete questionnaires; 8) with no significant brain lesions on routine MRI scans; 9) no other neurological diseases (such as cerebral hemorrhage, intracranial tumors, and Parkinson's disease history); 10) no current or past history of psychiatric illness; 11) no history of craniocerebral trauma, surgery, drug or alcohol dependence; 12) no severe other physical diseases (such as malignant tumors, heart disease, and kidney failure). 2.Healthy controls: 1) matched with tinnitus patients in age, gender, and education level, and without a history of tinnitus symptoms; 2) with no significant brain lesions on routine MRI scans; 3) no other neurological diseases (such as cerebral hemorrhage, intracranial tumors, and Parkinson's disease history); 4) no current or past history of psychiatric illness; 5) no history of craniocerebral trauma, surgery, drug or alcohol dependence; 6) no severe other physical diseases (such as malignant tumors, heart disease, and kidney failure); 7) volunteers who have signed the informed consent form and have good compliance.

Exclusion criteria

Exclusion criteria: 1.Tinnitus Subjects: 1)Patients with non-idiopathic or secondary tinnitus; 2) Conductive or mixed hearing loss confirmed via pure-tone audiometry; 3) Hearing threshold at dominant tinnitus frequency exceeding 60 dB; 4) Receipt of any tinnitus-related treatment within the past year; 5) Contraindications to MRI examination (including implanted cardiac pacemaker, intracranial/intraocular metallic foreign bodies, previous aneurysm clipping surgery, claustrophobia, pregnancy, etc.); 6) Intracranial lesions, hyperacusis or other central nervous system diseases; 7) Subjects who withdraw from the trial voluntarily for any reason during the study period. 2.Healthy Controls: 1) Subjects with contraindications for MRI examination (including metallic foreign bodies in the body, implanted cardiac pacemakers, intraocular metallic foreign bodies, prior aneurysm clipping, claustrophobia, pregnancy, etc.); 2) Poor cooperation during MRI scanning resulting in imaging artifacts for any reason; 3) Fazekas grade of cerebral white matter lesions higher than grade 2; 4) Subjects who voluntarily drop out of the study for any reason during the trial.

Design outcomes

Primary

MeasureTime frame
Aberrant amplitude low-frequency fluctuation,fractional aberrant amplitude low-frequency fluctuation, regional homogeneity, gray matter volume,white matter integrity,cerebral blood flow,quantitative s;Tinnitus Handicap Inventory,Visual Analogue Scale,Self-Rating Anxiety Scale,Self-Rating Depression Scale,Pittsburgh Sleep Quality Index Scale,Montreal Cognitive Assessment Scale;

Countries

China

Contacts

Public ContactQian Chen

Beijing Friendship Hospital ,Capital Medical University

chenqian8319@163.com+86 10 63138625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026