Clinical trial NCT06401993: 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"
Official title: 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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: Acupuncture
Fnirs
Tinnitus
ABR
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: By comparing the clinical manifestations, ABR parameters and cerebral cortex blood oxygen levels of chronic tinnitus patients and healthy subjects under two different body states, the peripheral-central correlation of chronic tinnitus patients was explored, and the modern scientific significance of the theory of "two ears connecting the brain" was initially expounded. On this basis, the immediate and cumulative effects and peripheral-central correlation of "dao qi tong luo" intervention in chronic tinnitus were observed, and the effective mechanism of "dao qi tong luo" treatment was explored.

Detailed description: The study will enroll 15 healthy subjects and 72 subjects with chronic tinnitus. Functional near infrared spectroscopy (fNIRS) will be used to examine specific brain regions, and ABR techniques will record auditory brainstem responses in chronic tinnitus patients and healthy subjects. Lateral comparison was made between chronic tinnitus patients and healthy subjects on the parameters of auditory brainstem response and the level of oxygen outside the cerebral cortex, and the data of the two were integrated to conduct correlation analysis and correlation analysis with clinical manifestations, so as to compare the correlation between peripheral and central auditory function in different body states. Subsequently, the chronic tinnitus subjects will undergo a course of acupuncture treatment. At the end of acupuncture and moxibustion treatment, the immediate and cumulative effects and peripheral - central correlation of "dao qi tong luo" intervention in chronic tinnitus were observed, and the effective mechanism of "dao qi tong luo" treatment was explored.

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.

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: at baseline (pre-treatment),procedure
Secondary outcomes:
measure: Tinnitus Evaluation Questionnaire (TEQ)
timeFrame: at baseline (pre-treatment), procedure
measure: Auditory Brainstem Response (ABR)
timeFrame: at baseline (pre-treatment), procedure
measure: Functional Near-Infrared Spectroscopy (Fnirs)
timeFrame: at baseline (pre-treatment), procedure
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Jie Zhou, M.D
role: PRINCIPAL_INVESTIGATOR
References: