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

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus; Therapy; Electroacupuncture; Neuromodulation; Cochlear Diseases
• Intervention / Treatment: Other: Electroacupuncture

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Normal population

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auditory brainstem response Wave I, III and V latency	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.	Day 0
Auditory brainstem response Wave I, III and V amplitude	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.	Day 0
Auditory brainstem response Wave I, III and V latency	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.	After electroacupuncture(Day 7)
Auditory brainstem response Wave I, III and V amplitude	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.	After electroacupuncture(Day 7)
Auditory brainstem response Wave I, III and V latency	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.	7 days after electroacupuncture(Day 14)
Auditory brainstem response Wave I, III and V amplitude	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.	7 days after electroacupuncture(Day 14)
Middle latency response wave Na, Pa, Nb, Pb latency	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.	Day 0
Middle latency response wave Na, Pa, Nb, Pb amplitude	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.	Day 0
Middle latency response wave Na, Pa, Nb, Pb latency	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.	After electroacupuncture(Day 7)
Middle latency response wave Na, Pa, Nb, Pb amplitude	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.	After electroacupuncture(Day 7)
Middle latency response wave Na, Pa, Nb, Pb latency	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.	7 days after electroacupuncture(Day 14)
Middle latency response wave Na, Pa, Nb, Pb amplitude	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.	7 days after electroacupuncture(Day 14)
Late latency response wave P1, N1, P2, N2 latency	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.	Day 0
Late latency response wave P1, N1, P2, N2 amplitude	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.	Day 0
Late latency response wave P1, N1, P2, N2 latency	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.	After electroacupuncture(Day 7)
Late latency response wave P1, N1, P2, N2 amplitude	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.	After electroacupuncture(Day 7)
Late latency response wave P1, N1, P2, N2 latency	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.	7 days after electroacupuncture(Day 14)
Late latency response wave P1, N1, P2, N2 amplitude	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.	7 days after electroacupuncture(Day 14)
p300 cortical response wave latency	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.	Day 0
p300 cortical response wave amplitude	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.	Day 0
p300 cortical response wave latency	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.	After electroacupuncture(Day 7)
p300 cortical response wave amplitude	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.	After electroacupuncture(Day 7)
p300 cortical response wave latency	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.	7 days after electroacupuncture(Day 14)
p300 cortical response wave amplitude	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.	7 days after electroacupuncture(Day 14)

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Study Chair: China Medical University, China Medical University, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2019
• Primary Completion (ACTUAL): July 24, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (ACTUAL): October 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus; Cochlear Diseases
• Other Study ID Numbers: CMUH103-REC2-149(CR-3)