Traumatic Brain Injury (TBI)NCT04930146
Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients
A study testing acupuncture and bloodletting in people with Traumatic Brain Injury (TBI), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Traumatic brain injury (Traumatic brain injury, TBI) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.There are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Traumatic Brain Injury (TBI)
- What is being tested?
- acupuncture and bloodletting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jun 2021to 7 Jun 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with moderate to severe head injury are admitted to the ICU (Intensive Care Unit). patient with stable vital sign and the GCS (Glasgow coma volume) between 5-13 will be included.
- Patient with normal consciousness and no cognitive or motor function disease before brain injury.
- Patient aged between 20 to 80 years old and is willing to sign the consent (the agent can sign on behalf of patient).
Who cannot join
- Patients who are vital sign unstable and with severe complication.
- Patients combined with other terminal illness such as cancer in terminal stage, liver failure, end stage renal failure and so on.
- Pregnant patients.
- Any other conditions deemed unsuitable by the physician in charge.
- Patients (agent of the patient) who did not sign the consent.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei
Wei Ling Chou, +886 975360906
Wei Ling Chou
About this study
Official title: To Evaluate the Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients
Traumatic brain injury (Traumatic brain injury, TBI) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.There are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury and can limit the progression of secondary brain injury, but the effect of early bloodletting at the Jing-points on TBI patients still unknown. In our study, the investigators have proposed a randomized, controlled study design and plan to evaluate the efficacy and safety of Jing-point puncture to improve consciousness and neurological function in patients with TBI. In addition, an objective meridian instrument analysis was added to analyze the energy distribution in the meridian of TBI patients.
- Conditions
- Traumatic Brain Injury (TBI)
- Being tested
- acupuncture and bloodletting
- Keywords
- Traumatic brain injury, TBI, Bloodletting, acupuncture
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture and bloodlettingOther
bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Severe) | Experimental | A patient's Glasgow Coma Score (GCS) between 5-8
1. Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments.
2. Evaluating the meridian energy by M.E.A.D Receives: Other: acupuncture and bloodletting |
| Control group (Severe) | No intervention | A patient's Glasgow Coma Score (GCS) between 5-8 1. Conventional treatment. 2. Evaluating the meridian energy by M.E.A.D |
| Intervention group (Moderate) | Experimental | A patient's Glasgow Coma Score (GCS) between 9-13
1. Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments.
2. Evaluating the meridian energy by M.E.A.D Receives: Other: acupuncture and bloodletting |
| Control group (moderate) | No intervention | A patient's Glasgow Coma Score (GCS) between 9-13 1. Conventional treatment. 2. Evaluating the meridian energy by M.E.A.D |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCS(Glasgow Coma Scale)
To assess the recovery of consciousness. Lower GCS scores are correlated with higher risk of death.
Measured: 4 weeks
Barthel index
To assess the activities of daily life.
Measured: 4 weeks
Muscle power
To assess the recovery of muscle power.
Measured: 4 weeks
mGOS(Modified Glasgow Outcome Score)
To assess the neurological outcomes, score 1 to 5. the higher the score, the better outcome.
Measured: 4 weeks
RTS (Revised Trauma Score)
To assess the physiologic condition of patients. The Revised Trauma Score is made up of a three categories: Glasgow Coma Scale, systolic blood pressure, and respiratory rate. The score range is 0-12. A lower score indicates a higher severity of injury.
Measured: 4 weeks
Secondary outcomes (1)
Meridian energy assessment
To assess meridian energy by Meridian Energy Analysis Device (M.E.A.D. )
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start8 Jun 2021
- Primary completion7 Jun 2024 (estimated)
- Study completion7 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wei Ling Chou, Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930146
- Sponsor's protocol ID
- 202100683A3
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients
- ClinicalTrials.gov ID
- NCT04930146
- Acronym / sponsor ID
- 202100683A3
- Conditions
- Traumatic Brain Injury (TBI)
- Keywords
- Traumatic brain injury, TBI, Bloodletting, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 7 Jun 2024 (estimated)
- Study completion
- 7 Jun 2024 (estimated)
- First posted
- 18 Jun 2021 (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 (Traumatic brain injury, TBI) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.There are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury and can limit the progression of secondary brain injury, but the effect of early bloodletting at the Jing-points on TBI patients still unknown. In our study, the investigators have proposed a randomized, controlled study design and plan to evaluate the efficacy and safety of Jing-point puncture to improve consciousness and neurological function in patients with TBI. In addition, an objective meridian instrument analysis was added to analyze the energy distribution in the meridian of TBI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Severe) | Experimental | Other: acupuncture and bloodlettingA patient's Glasgow Coma Score (GCS) between 5-8 1. Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments. 2. Evaluating the meridian energy by M.E.A.D |
| Control group (Severe) | No intervention | –A patient's Glasgow Coma Score (GCS) between 5-8 1. Conventional treatment. 2. Evaluating the meridian energy by M.E.A.D |
| Intervention group (Moderate) | Experimental | Other: acupuncture and bloodlettingA patient's Glasgow Coma Score (GCS) between 9-13 1. Conventional treatment and bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments. 2. Evaluating the meridian energy by M.E.A.D |
| Control group (moderate) | No intervention | –A patient's Glasgow Coma Score (GCS) between 9-13 1. Conventional treatment. 2. Evaluating the meridian energy by M.E.A.D |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with moderate to severe head injury are admitted to the ICU (Intensive Care Unit). patient with stable vital sign and the GCS (Glasgow coma volume) between 5-13 will be included.
- Patient with normal consciousness and no cognitive or motor function disease before brain injury.
- Patient aged between 20 to 80 years old and is willing to sign the consent (the agent can sign on behalf of patient).
Key exclusion criteria (5 listed)
- Patients who are vital sign unstable and with severe complication.
- Patients combined with other terminal illness such as cancer in terminal stage, liver failure, end stage renal failure and so on.
- Pregnant patients.
- Any other conditions deemed unsuitable by the physician in charge.
- Patients (agent of the patient) who did not sign the consent.
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 |
|---|---|---|
| acupuncture and bloodlettingbloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments. | Other | Intervention group (Moderate), Intervention group (Severe) |
Primary outcome
GCS(Glasgow Coma Scale)
Time frame: 4 weeks
To assess the recovery of consciousness. Lower GCS scores are correlated with higher risk of death.
Barthel index
Time frame: 4 weeks
To assess the activities of daily life.
Muscle power
Time frame: 4 weeks
To assess the recovery of muscle power.
mGOS(Modified Glasgow Outcome Score)
Time frame: 4 weeks
To assess the neurological outcomes, score 1 to 5. the higher the score, the better outcome.
RTS (Revised Trauma Score)
Time frame: 4 weeks
To assess the physiologic condition of patients. The Revised Trauma Score is made up of a three categories: Glasgow Coma Scale, systolic blood pressure, and respiratory rate. The score range is 0-12. A lower score indicates a higher severity of injury.
1 secondary outcome
Meridian energy assessment
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No
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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.
wei Ling Chou principal investigator
Chang Gung Medical Foundation
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 and bloodletting in people with Traumatic Brain Injury (TBI), run by Chang Gung Memorial 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 3 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 21 Jun 2021. 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. 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 wei Ling Chou (+886 975360906, wenni1207@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCS(Glasgow Coma Scale) (time frame: 4 weeks). The study lists 5 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 21 Jun 2021.