Exploring acupuncture effects on chronic tinnitus and brain function

Peripheral-central Correlation Study on the Treatment of Chronic Tinnitus With "Dao qi Tong Luo" Based on the Theory of "Connecting the Two Ears to the Brain"

This study is testing whether acupuncture can help people with chronic tinnitus feel better and improve their brain function compared to healthy individuals.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 20 Years to 55 Years
• Sex: All
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University (other)
• Locations: 1 site (Hangzhou)
• Trial ID: NCT06401993 on ClinicalTrials.gov

What this trial studies

This study investigates the relationship between peripheral and central auditory functions in chronic tinnitus patients compared to healthy individuals. It will enroll 72 chronic tinnitus patients and 15 healthy subjects, utilizing functional near-infrared spectroscopy (fNIRS) to assess brain activity and auditory brainstem response (ABR) techniques to measure auditory function. Participants will undergo acupuncture treatment based on the 'dao qi tong luo' approach, with the aim of observing both immediate and cumulative effects on tinnitus symptoms and brain function. The study seeks to elucidate the mechanisms behind the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 20 to 55 with chronic tinnitus lasting at least six months and no significant hearing loss.

Not a fit: Patients with a history of drug dependence, serious central nervous system disorders, or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new insights and effective treatment options for patients suffering from chronic tinnitus.

How similar studies have performed: While acupuncture has been explored in other studies for tinnitus, this specific approach integrating fNIRS and ABR is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Inclusion criteria for patients with chronic tinnitus

  1. Chronic tinnitus patients, that is, the course of disease ≥6 months;
  2. No contraindications of fNIRS scanning;
  3. The age of 20 years ≤55 years old, gender is not limited, right-handed;
  4. The external ear canal is unobstructed and the eardrum is intact
  5. The average hearing threshold of both ears is \<35dB;
  6. Normal expression and understanding ability. Inclusion criteria for healthy subjects

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  1. No tinnitus, no hearing disorders and other ear diseases;
  2. Good health condition, no history of mental disease and nervous system disease;
  3. No contraindications of fNIRS scanning;
  4. The age of 20 years ≤55 years old, gender is not limited, right-handed;
  5. The external ear canal is unobstructed, and the tympanic membrane is complete;
  6. Normal expression and understanding ability.

Exclusion Criteria:

* 1.A history of drug dependence or alcohol addiction; 2.Serious central system diseases or other systemic diseases such as cardiovascular and cerebrovascular diseases; 3. Patients with organic diseases such as craniocerebral trauma; 4. Sudden deafness, Meniere's disease, otosclerosis, acoustic neuroma and other inner ear or auditory nerve diseases; 5.External otitis, acute/chronic otitis media and other external ear middle-ear related diseases; 6. Patients with auditory hypersensitivity; 7. Pregnancy, preparation for pregnancy, breastfeeding population; 8. There are metal implants in the body, fNIRS detection contraindicated.

Where this trial is running

Hangzhou

• The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, China (RECRUITING)

Study contacts

• Principal investigator: Jie Zhou, M.D — The Third Affiliated hospital of Zhejiang Chinese Medical University
• Study coordinator: Da Jiang, M.M

Conditions: Tinnitus, Acupuncture, Fnirs, ABR