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🔬 Active Clinical Trial: NCT07522567 | Status: NOT_YET_RECRUITING | Phase: NA

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Acupuncture Trial Aims to Link Subjective Tinnitus Relief to Brainstem Activity

A new study protocol aims to measure the physiological impact of acupuncture on the brain’s auditory pathways in people with chronic tinnitus. The trial, registered as NCT07522567, will attempt to correlate changes in a patient’s perceived tinnitus severity with objective neurophysiological data from auditory brainstem response (ABR) tests. For the 72 planned participants, this approach could move the discussion about acupuncture’s role in tinnitus management from subjective report to measurable biology.

Key Takeaways

  • The trial will treat adults with chronic tinnitus with a 10-session acupuncture course, measuring outcomes with the Tinnitus Handicap Inventory (THI) and Tinnitus Effects Questionnaire (TEQ).
  • Its primary goal is to find an objective link between symptom relief and changes in auditory brainstem response (ABR) parameters, such as wave I amplitude and wave V latency.
  • Researchers will compare 36 tinnitus patients to 36 age- and sex-matched healthy controls to identify baseline abnormalities.
  • The study is not yet recruiting participants and has specific criteria, excluding individuals with head trauma, metallic implants, or other active health conditions.
  • Results could provide a physiological basis for acupuncture’s reported benefits, informing more targeted treatment strategies.

A Dual-Pronged Study Design: Cases, Controls, and Self-Comparison

The trial employs a matched case-control and self-controlled design. First, researchers will compare ABR readings from 36 adults with chronic tinnitus against readings from 36 healthy controls matched for age and sex. This step aims to characterize the specific neurophysiological abnormalities associated with tinnitus. Second, within the patient group, investigators will analyze changes from before treatment to after treatment. Each participant with tinnitus will receive ten acupuncture sessions. The study’s primary clinical tools are the Tinnitus Handicap Inventory (THI) and the Tinnitus Effects Questionnaire (TEQ), standardized instruments for assessing the functional and emotional impact of the condition.

Scientific Rationale: Connecting Perception to Neural Conduction

Tinnitus is the perception of sound without an external source. While often linked to hearing loss, its mechanisms involve complex neural networks, including the auditory brainstem. The Auditory Brainstem Response (ABR) test measures the electrical activity of the auditory nerve and brainstem pathways in response to sound. Specific ABR wave patterns, like the amplitude of wave I (from the auditory nerve) and the latency of wave V (from the midbrain), can indicate the health and timing of this neural conduction. Some research suggests these measures are altered in people with tinnitus. This trial is built on the hypothesis that if acupuncture provides relief, it may also normalize these observable ABR parameters, offering a potential biological marker for treatment effect.

Participation Criteria and Current Trial Status

The study is currently listed as NOT_YET_RECRUITING. It seeks adults aged 18 to 60 who have chronic tinnitus but are otherwise healthy. Key inclusion criteria require participants to have no history of chronic organic diseases, head injury, or psychiatric/neurological family genetic diseases. Major exclusions include pregnancy, breastfeeding, having metallic implants in the body (which contraindicates ABR testing), or current participation in another interventional trial. These strict criteria are intended to create a homogenous study group, reducing variables that could confuse the data on acupuncture’s specific effects.

Potential Impact on Tinnitus Treatment and Research

Positive results from this trial would serve two main functions. For patients, it could strengthen the evidence base for acupuncture as a viable management option for chronic tinnitus, providing data on both symptom relief and a plausible mechanism. For researchers and clinicians, establishing a correlation between improved THI/TEQ scores and normalized ABR measures would be significant. It would introduce an objective, physiological metric to a field that heavily relies on subjective reporting. This could improve future clinical trials by providing a secondary, biological endpoint and guide the development of therapies that target specific auditory pathway dysfunctions. The study does not test a drug or device but investigates a procedural intervention, seeking to understand how a traditional practice might alter modern neurophysiological readings.

This article is for informational purposes only. Consult a qualified professional for personalised advice.


Source:
Efficacy of Acupuncture on Chronic Tinnitus and Its Association With Auditory Brainstem Response Measures (ClinicalTrials.gov: NCT07522567)

Medical Disclaimer

This article is for informational purposes only and does not constitute medical advice. The research summaries presented here are based on published studies and should not be used as a substitute for professional medical consultation. Always consult a qualified healthcare provider before making any changes to your health regimen.

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