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NCT Number: NCT05591807

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

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.

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Key information

Conditions

Tinnitus Cochlear Diseases Ear Diseases Electroacupuncture Hearing Disorders Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Neuromodulation Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Therapy

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University

Taichung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroacupuncture

Other

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

Primary outcomes

  1. Auditory brainstem response Wave I, III and V latency

    Time frame: Day 0

    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.

  2. Auditory brainstem response Wave I, III and V amplitude

    Time frame: Day 0

    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.

  3. Auditory brainstem response Wave I, III and V latency

    Time frame: After electroacupuncture(Day 7)

    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.

  4. Auditory brainstem response Wave I, III and V amplitude

    Time frame: After electroacupuncture(Day 7)

    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.

  5. 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.

  6. 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.

  7. Middle latency response wave Na, Pa, Nb, Pb latency

    Time frame: Day 0

    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.

  8. Middle latency response wave Na, Pa, Nb, Pb amplitude

    Time frame: Day 0

    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.

  9. Middle latency response wave Na, Pa, Nb, Pb latency

    Time frame: After electroacupuncture(Day 7)

    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.

  10. Middle latency response wave Na, Pa, Nb, Pb amplitude

    Time frame: After electroacupuncture(Day 7)

    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.

  11. 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.

  12. 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.

  13. Late latency response wave P1, N1, P2, N2 latency

    Time frame: Day 0

    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.

  14. Late latency response wave P1, N1, P2, N2 amplitude

    Time frame: Day 0

    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.

  15. Late latency response wave P1, N1, P2, N2 latency

    Time frame: After electroacupuncture(Day 7)

    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.

  16. Late latency response wave P1, N1, P2, N2 amplitude

    Time frame: After electroacupuncture(Day 7)

    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.

  17. 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.

  18. 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.

  19. p300 cortical response wave latency

    Time frame: Day 0

    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.

  20. p300 cortical response wave amplitude

    Time frame: Day 0

    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.

  21. p300 cortical response wave latency

    Time frame: After electroacupuncture(Day 7)

    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.

  22. p300 cortical response wave amplitude

    Time frame: After electroacupuncture(Day 7)

    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.

  23. 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.

  24. 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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2022
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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