Clinical trial NCT05839132: Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients
Official title: Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neurodegenerative Diseases
Keywords: Acupuncture
Traumatic Brain Injury
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: plasma levels of Aβ peptide
timeFrame: After 2-week acupuncture treatment interva
measure: plasma levels of tau
timeFrame: After 2-week acupuncture treatment interva
measure: plasma levels of glial fibrillary acidic protein (GFAP)
timeFrame: After 2-week acupuncture treatment interva
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: