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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591807
• Other study ID #: CMUH103-REC2-149(CR-3)
• Status: Completed
• Start date: July 2, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2022
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Diseases
• Electroacupuncture
• Neuromodulation
• Therapy
• Tinnitus

Intervention

Other:
• Electroacupuncture
insert the acupuncture needle to SJ3(left side) and connect the electroacupuncture device for 15min, 2mA and 2Hz

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)