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Clinical Trials/NCT05591807
NCT05591807
Completed
Not Applicable

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

China Medical University Hospital1 site in 1 country10 target enrollmentJuly 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tinnitus
Sponsor
China Medical University Hospital
Enrollment
10
Locations
1
Primary Endpoint
Auditory brainstem response Wave I, III and V amplitude
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2019
End Date
September 30, 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Auditory brainstem response Wave I, III and V amplitude

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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