Neurodegenerative DiseasesNCT05839132
Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients
A study testing Acupuncture in people with Neurodegenerative Diseases, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
China Medical University Hospital
Taichung, 404
Yu-Chen Lee, Ph.D, 886-975-682023, d5167@mail.cmuh.org.tw
About this study
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
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Traumatic Brain Injury
- Medical subject headings
- Neurodegenerative Diseases, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma levels of Aβ peptide
Decreased plasma levels of Aβ peptide
Measured: After 2-week acupuncture treatment interva
plasma levels of tau
Decreased plasma levels of tau
Measured: After 2-week acupuncture treatment interva
plasma levels of glial fibrillary acidic protein (GFAP)
Decreased plasma levels of glial fibrillary acidic protein (GFAP)
Measured: After 2-week acupuncture treatment interva
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839132
- Sponsor's protocol ID
- CMUH111-REC1-239
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT05839132
- Acronym / sponsor ID
- CMUH111-REC1-239
- Conditions
- Neurodegenerative Diseases
- Keywords
- Acupuncture, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture treatment group | Experimental | Procedure: AcupunctureDisposable 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) |
| sham acupuncture treatment group | Placebo comparator | Procedure: AcupunctureStreitberger'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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes. | Procedure or surgery | acupuncture treatment group, sham acupuncture treatment group |
Primary outcome
plasma levels of Aβ peptide
Time frame: After 2-week acupuncture treatment interva
Decreased plasma levels of Aβ peptide
plasma levels of tau
Time frame: After 2-week acupuncture treatment interva
Decreased plasma levels of tau
plasma levels of glial fibrillary acidic protein (GFAP)
Time frame: After 2-week acupuncture treatment interva
Decreased plasma levels of glial fibrillary acidic protein (GFAP)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Neurodegenerative Diseases, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chen Lee, Ph.D (+886-975-682023, d5167@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma levels of Aβ peptide (time frame: After 2-week acupuncture treatment interva). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.