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Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract

Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract by Electroacupuncture and Its Clinical Therapeutic Implications

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05591807
Enrollment
10
Registered
2022-10-24
Start date
2019-07-02
Completion date
2019-09-30
Last updated
2022-10-24

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

Conditions

Cochlear Diseases, Electroacupuncture, Neuromodulation, Therapy, Tinnitus

Brief summary

Tinnitus is the awareness of sound or noise in the absence of acoustic stimulation. No definite therapeutic strategy of tinnitus has been developed yet. The current theory of tinnitus is the plasticity theory of neurophysiology model. Although acupuncture has its role in tinnitus treatment, its actual role still remains to be elucidated. Acupuncture has been proposed to induce the development of neuroplasticity. The aim of this project is to undergo a comprehensive investigation to the central auditory effect and the therapeutic effects of acupuncture in tinnitus. According the results of the preliminary studies, the objective auditory measurement and subjective tinnitus perception will be analyzed in tinnitus patients before and after acupuncture.

Detailed description

Hearing loss is a common sensory deficit in human beings. Besides communication handicaps, hearing loss may associate with niggling tinnitus symptoms. Tinnitus is the awareness of sound or noise in the absence of acoustic stimulation. Tinnitus may cause bothersome problems in cognition, mood, or psychosocial behaviour and constitute a significant portion in the outpatient clinics of ENT practice. No definite therapeutic strategy of tinnitus has been developed yet. The current theory of tinnitus is the plasticity theory of neurophysiology model. According to this theory, several neuromodulation methods have been proposed such as repetitive transcranial magnetic stimulation (rTMS) or vagus nerve stimulation (VNS). Although acupuncture has its role in tinnitus treatment, its actual role still remains to be elucidated. Acupuncture has been proposed to induce the development of neuroplasticity. There are still few thorough researches to investigate the neurophysiological events after acupuncture. The aim of this project is to undergo a comprehensive investigation to the central auditory effect and the therapeutic effects of acupuncture in tinnitus. According the results of the preliminary studies, the objective auditory measurement and subjective tinn itus perception will be analyzed in tinnitus patients before and after acupuncture. The ultimate results of this project will clarify the basic central auditory effects of acupuncture and provide a potential for translational application of acupuncture to treat the common tinnitus patients.

Interventions

OTHERElectroacupuncture

insert the acupuncture needle to SJ3(left side) and connect the electroacupuncture device for 15min, 2mA and 2Hz

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-30 y/o * Normal hearing * No acupuncture contraindication

Exclusion criteria

* Heart disease or other acupuncture contraindication * Bleeding tendency * Autoimmune disease * Drug abuse * Pregnant or breast-feeding * Hearing loss * Active otitis media or inner ear diseases or retro-cochlear pathology * Incomplete treatment

Design outcomes

Primary

MeasureTime frameDescription
Auditory brainstem response Wave I, III and V latencyDay 0An audiologist places small earphones in the ears and electrodes near the ears and on the forehead. Clicking sounds and tones go through the earphones, and electrodes measure how the hearing nerves and brain respond to the sounds.
Auditory brainstem response Wave I, III and V amplitudeDay 0An audiologist places small earphones in the ears and electrodes near the ears and on the forehead. Clicking sounds and tones go through the earphones, and electrodes measure how the hearing nerves and brain respond to the sounds.
Middle latency response wave Na, Pa, Nb, Pb latencyDay 0An audiologist places small earphones in the ears and electrodes near the ears and on the forehead. Clicking sounds and tones go through the earphones, and electrodes measure how the hearing nerves and brain respond to the sounds.
Middle latency response wave Na, Pa, Nb, Pb amplitudeDay 0An audiologist places small earphones in the ears and electrodes near the ears and on the forehead. Clicking sounds and tones go through the earphones, and electrodes measure how the hearing nerves and brain respond to the sounds.
Late latency response wave P1, N1, P2, N2 latencyDay 0An audiologist places small earphones in the ears and electrodes near the ears and on the forehead. Clicking sounds and tones go through the earphones, and electrodes measure how the hearing nerves and brain respond to the sounds.
Late latency response wave P1, N1, P2, N2 amplitudeDay 0An audiologist places small earphones in the ears and electrodes near the ears and on the forehead. Clicking sounds and tones go through the earphones, and electrodes measure how the hearing nerves and brain respond to the sounds.
p300 cortical response wave latencyDay 0An audiologist places small earphones in the ears and electrodes near the ears and on the forehead. Clicking sounds and tones go through the earphones, and electrodes measure how the hearing nerves and brain respond to the sounds.
p300 cortical response wave amplitudeDay 0An audiologist places small earphones in the ears and electrodes near the ears and on the forehead. Clicking sounds and tones go through the earphones, and electrodes measure how the hearing nerves and brain respond to the sounds.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026