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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neurodegenerative Diseases

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture treatment group<br>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<br>* 20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.<br>|
| Placebo Comparator: sham acupuncture treatment group<br>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<br>* 20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Traumatic Brain Injury