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

Completed

• Conditions: Neuromodulation; Cochlear Diseases; Tinnitus; Therapy; Electroacupuncture

• Registration Number: NCT05591807
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2019-07-02
• Primary Completion: 2019-07-24
• Study Completion: 2019-09-30
• Study First Submitted: 2022-09-13
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-19
• Last Update Submitted: 2022-10-19
• Study First Posted: 2022-10-24
• Last Update Posted: 2022-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Auditory brainstem response Wave I, III and V amplitude	7 days after electroacupuncture(Day 14)	An 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 latency	7 days after electroacupuncture(Day 14)	An 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 latency	7 days after electroacupuncture(Day 14)	An 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 amplitude	7 days after electroacupuncture(Day 14)	An 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 amplitude	7 days after electroacupuncture(Day 14)	An 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 latency	7 days after electroacupuncture(Day 14)	An 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 amplitude	7 days after electroacupuncture(Day 14)	An 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 latency	7 days after electroacupuncture(Day 14)	An 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.

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan