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

• Sponsor: China Medical University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05839132
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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 density maps of TBI patients overlapped with those with Alzheimer's disease, and increased Aβ density not only associated with prolonged TBI duration but also associated with decreased white matter integrity. It has been suggested that the axonal injury and cerebrovascular dysfunction due to TBI may associate with the elevated level of Aβ peptides. The increasing accumulation in Aβ due to TBI may contribute to the initiation of the pathological alterations in neurodegeneration diseases. Recent animal studies suggest that acupuncture may promote regeneration of nerves in injured tissues and reduce the concentration of Aβ in brain. Moreover, recent clinical trials also indicate that acupuncture may improve the vascular cognitive impairment due to cerebral small vessel disease. Thus, acupuncture treatment on TBI may not only be of benefit for the TBI recovery but also act to interrupt the pathological changes in these neurodegenerative diseases.

Condition or Disease	Intervention/Treatment	Phase
Neurodegenerative Diseases	Procedure: Acupuncture	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Jul 31, 2026
• Anticipated Study Completion Date: Jul 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: acupuncture 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)	Procedure: Acupuncture; 20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.
Placebo Comparator: sham 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)	Procedure: Acupuncture; 20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.

Outcome Measures

Primary Outcome Measures

1. plasma levels of Aβ peptide [After 2-week acupuncture treatment interva]

   Decreased plasma levels of Aβ peptide

2. plasma levels of tau [After 2-week acupuncture treatment interva]

   Decreased plasma levels of tau

3. plasma levels of glial fibrillary acidic protein (GFAP) [After 2-week acupuncture treatment interva]

   Decreased plasma levels of glial fibrillary acidic protein (GFAP)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University Hospital	Taichung		Taiwan	404

Sponsors and Collaborators

• China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yu-Chen Lee, professor, China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT05839132
• Other Study ID Numbers: CMUH111-REC1-239
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yu-Chen Lee, professor, China Medical University Hospital: Acupuncture; Traumatic Brain Injury
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Neurodegenerative Diseases

Study Results

No Results Posted as of May 3, 2023