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

NCT05839132 | Not Yet Recruiting

• 1 other identifier: CMUH111-REC1-239
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases

Keywords

Acupuncture; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

acupuncture treatment group

EXPERIMENTAL

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

sham acupuncture treatment group

PLACEBO COMPARATOR

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

Interventions

Acupuncture PROCEDURE

20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.

acupuncture treatment group; sham acupuncture treatment group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 20 years old
• GCS score \> 8
• loss of consciousness \< 24 hr
• the physical condition is suitable for acupuncture treatment
• having adequate competency for understanding the study and a willingness to sign the written informed consent forms
• be able to commence the acupuncture intervention within 2 weeks after TBI diagnosis

You may not qualify if:

• medical history of neurological, cardiovascular events, e.g., epilepsy, stroke, major depression or anxiety
• a history of the mental disorder, e.g., major depression or anxiety
• other major medical conditions, e.g., active cancer, uncontrolled diabetes, amputation
• receipt of acupuncture within the 6 months prior to study entry
• patients with pacemaker or metal graf

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Neurodegenerative Diseases; Brain Injuries, Traumatic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Yu-Chen Lee, Ph.D

CONTACT

+886-975-682023; d5167@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

TW (1)