Clinical trial NCT05591807: Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract
Official title: Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract by Electroacupuncture and Its Clinical Therapeutic Implications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Neuromodulation
Electroacupuncture
Cochlear Diseases
Therapy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal population

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.

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

Primary outcomes:
measure: Auditory brainstem response Wave I, III and V latency
timeFrame: Day 0
measure: Auditory brainstem response Wave I, III and V amplitude
timeFrame: Day 0
measure: Auditory brainstem response Wave I, III and V latency
timeFrame: After electroacupuncture(Day 7)
measure: Auditory brainstem response Wave I, III and V amplitude
timeFrame: After electroacupuncture(Day 7)
measure: Auditory brainstem response Wave I, III and V latency
timeFrame: 7 days after electroacupuncture(Day 14)
measure: Auditory brainstem response Wave I, III and V amplitude
timeFrame: 7 days after electroacupuncture(Day 14)
measure: Middle latency response wave Na, Pa, Nb, Pb latency
timeFrame: Day 0
measure: Middle latency response wave Na, Pa, Nb, Pb amplitude
timeFrame: Day 0
measure: Middle latency response wave Na, Pa, Nb, Pb latency
timeFrame: After electroacupuncture(Day 7)
measure: Middle latency response wave Na, Pa, Nb, Pb amplitude
timeFrame: After electroacupuncture(Day 7)
measure: Middle latency response wave Na, Pa, Nb, Pb latency
timeFrame: 7 days after electroacupuncture(Day 14)
measure: Middle latency response wave Na, Pa, Nb, Pb amplitude
timeFrame: 7 days after electroacupuncture(Day 14)
measure: Late latency response wave P1, N1, P2, N2 latency
timeFrame: Day 0
measure: Late latency response wave P1, N1, P2, N2 amplitude
timeFrame: Day 0
measure: Late latency response wave P1, N1, P2, N2 latency
timeFrame: After electroacupuncture(Day 7)
measure: Late latency response wave P1, N1, P2, N2 amplitude
timeFrame: After electroacupuncture(Day 7)
measure: Late latency response wave P1, N1, P2, N2 latency
timeFrame: 7 days after electroacupuncture(Day 14)
measure: Late latency response wave P1, N1, P2, N2 amplitude
timeFrame: 7 days after electroacupuncture(Day 14)
measure: p300 cortical response wave latency
timeFrame: Day 0
measure: p300 cortical response wave amplitude
timeFrame: Day 0
measure: p300 cortical response wave latency
timeFrame: After electroacupuncture(Day 7)
measure: p300 cortical response wave amplitude
timeFrame: After electroacupuncture(Day 7)
measure: p300 cortical response wave latency
timeFrame: 7 days after electroacupuncture(Day 14)
measure: p300 cortical response wave amplitude
timeFrame: 7 days after electroacupuncture(Day 14)
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: China Medical University, China
name: China Medical University
role: STUDY_CHAIR
References: