Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedOctober 24, 2022
October 1, 2022
22 days
September 13, 2022
October 19, 2022
Conditions
Outcome Measures
Primary Outcomes (24)
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)
Interventions
insert the acupuncture needle to SJ3(left side) and connect the electroacupuncture device for 15min, 2mA and 2Hz
Eligibility Criteria
Normal population
You may qualify if:
- y/o
- Normal hearing
- No acupuncture contraindication
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University
Taichung, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
China Medical University
China Medical University, China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2022
First Posted
October 24, 2022
Study Start
July 2, 2019
Primary Completion
July 24, 2019
Study Completion
September 30, 2019
Last Updated
October 24, 2022
Record last verified: 2022-10