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Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients 76

Not yet recruiting
Clinical Trial NCT05839132 is an interventional study for Neurodegenerative Diseases and is currently not yet recruiting. Enrollment is planned to begin on 1 August 2023 and continue until the study accrues 76 participants. Led by China Medical University Hospital, this study is expected to complete by 31 July 2026. The latest data from ClinicalTrials.gov was last updated on 3 May 2023.
Brief Summary
Traumatic brain injury (TBI) is an altered brain function caused by an external force, which may annually have 69 million incidence cases all over the world. Increasing evidence suggests that TBI may be a major risk of beta amyloid (Aβ)-associated neurodegenerative disorders, such as Alzheimer's disease, frontotemporal dementia, and Parkinson's disease. Investigations from brain imaging studies revealed that Aβ densi...Show More
Official Title

Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients

Conditions
Neurodegenerative Diseases
Other Study IDs
  • CMUH111-REC1-239
NCT ID Number
NCT05839132
Start Date (Actual)
2023-08-01
Last Update Posted
2023-05-03
Completion Date (Estimated)
2026-07-31
Enrollment (Estimated)
76
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Acupuncture
Traumatic Brain Injury
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalacupuncture treatment group
Disposable acupuncture needles will be inserted into acupoints for a depth of 20-30 mm in a direction oblique or parallel to the surface. To ensure allocation concealment, all needles will be affixed with plastic O-rings and adhesive tapes. Acupuncture points: Baihui(DU20), Sishencong(EM1), Hegu(LI4), Taichong(LR3)
Acupuncture
20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.
Placebo Comparatorsham acupuncture treatment group
Streitberger's non-invasive placebo acupuncture needles will be used in the control group; blunt-tipped needles will touch the skin quickly without being inserted. To ensure allocation concealment, all needles will be affixed with plastic O-rings and adhesive tapes. Acupuncture points: Baihui(DU20), Sishencong(EM1), Hegu(LI4), Taichong(LR3)
Acupuncture
20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
plasma levels of Aβ peptide
Decreased plasma levels of Aβ peptide
After 2-week acupuncture treatment interva
plasma levels of tau
Decreased plasma levels of tau
After 2-week acupuncture treatment interva
plasma levels of glial fibrillary acidic protein (GFAP)
Decreased plasma levels of glial fibrillary acidic protein (GFAP)
After 2-week acupuncture treatment interva
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
20 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  1. age ≥ 20 years old
  2. GCS score > 8
  3. loss of consciousness < 24 hr
  4. the physical condition is suitable for acupuncture treatment
  5. having adequate competency for understanding the study and a willingness to sign the written informed consent forms
  6. be able to commence the acupuncture intervention within 2 weeks after TBI diagnosis

  1. medical history of neurological, cardiovascular events, e.g., epilepsy, stroke, major depression or anxiety
  2. a history of the mental disorder, e.g., major depression or anxiety
  3. other major medical conditions, e.g., active cancer, uncontrolled diabetes, amputation
  4. receipt of acupuncture within the 6 months prior to study entry
  5. patients with pacemaker or metal graf
China Medical University Hospital logoChina Medical University Hospital101 active studies to explore
Study Responsible Party
Yu-Chen Lee, Principal Investigator, professor, China Medical University Hospital
Study Central Contact
Contact: Yu-Chen Lee, Ph.D, +886-975-682023, [email protected]
1 Study Locations in 1 Countries
China Medical University Hospital, Taichung, 404, Taiwan
Yu-Chen Lee, Ph.D, Contact, 886-975-682023, [email protected]