Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients

Study Overview
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Brief Summary
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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.

Official Title
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To Evaluate the Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients

Conditions
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Traumatic Brain Injury (TBI)

Intervention / Treatment
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* Other: acupuncture and bloodletting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (Severe)<br>A patient's Glasgow Coma Score (GCS) between 5-8 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. Evaluating the meridian energy by M.E.A.D | Other: acupuncture and bloodletting<br>* 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.<br>|
| No Intervention: Control group (Severe)<br>A patient's Glasgow Coma Score (GCS) between 5-8 Conventional treatment. Evaluating the meridian energy by M.E.A.D | |
| Experimental: Intervention group (Moderate)<br>A patient's Glasgow Coma Score (GCS) between 9-13 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. Evaluating the meridian energy by M.E.A.D | Other: acupuncture and bloodletting<br>* 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.<br>|
| No Intervention: Control group (moderate)<br>A patient's Glasgow Coma Score (GCS) between 9-13 Conventional treatment. Evaluating the meridian energy by M.E.A.D | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GCS(Glasgow Coma Scale) | To assess the recovery of consciousness. Lower GCS scores are correlated with higher risk of death. | 4 weeks | 
| Barthel index | To assess the activities of daily life. | 4 weeks | 
| Muscle power | To assess the recovery of muscle power. | 4 weeks | 
| mGOS(Modified Glasgow Outcome Score) | To assess the neurological outcomes, score 1 to 5. the higher the score, the better outcome. | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meridian energy assessment | To assess meridian energy by Meridian Energy Analysis Device (M.E.A.D. ) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, TBI, Bloodletting, acupuncture