search
Back to results

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

Primary Purpose

Neurodegenerative Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurodegenerative Diseases focused on measuring Acupuncture, Traumatic Brain Injury

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

acupuncture treatment group

sham acupuncture treatment group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

plasma levels of Aβ peptide
Decreased plasma levels of Aβ peptide
plasma levels of tau
Decreased plasma levels of tau
plasma levels of glial fibrillary acidic protein (GFAP)
Decreased plasma levels of glial fibrillary acidic protein (GFAP)

Secondary Outcome Measures

Full Information

First Posted
April 20, 2023
Last Updated
April 20, 2023
Sponsor
China Medical University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05839132
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodegenerative Diseases
Keywords
Acupuncture, Traumatic Brain Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acupuncture treatment group
Arm Type
Experimental
Arm Description
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)
Arm Title
sham acupuncture treatment group
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.
Primary Outcome Measure Information:
Title
plasma levels of Aβ peptide
Description
Decreased plasma levels of Aβ peptide
Time Frame
After 2-week acupuncture treatment interva
Title
plasma levels of tau
Description
Decreased plasma levels of tau
Time Frame
After 2-week acupuncture treatment interva
Title
plasma levels of glial fibrillary acidic protein (GFAP)
Description
Decreased plasma levels of glial fibrillary acidic protein (GFAP)
Time Frame
After 2-week acupuncture treatment interva

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Chen Lee, Ph.D
Phone
+886-975-682023
Email
d5167@mail.cmuh.org.tw
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Chen Lee, Ph.D
Phone
886-975-682023
Email
d5167@mail.cmuh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs