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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury (TBI)
• Intervention / Treatment: Other: acupuncture and bloodletting

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wei Ling Chou; Phone Number: +886 975360906; Email: wenni1207@cgmh.org.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Wei Ling Chou; Phone Number: +886 975360906
    • Principal Investigator: Wei Ling Chou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Patient with normal consciousness and no cognitive or motor function disease before brain injury.
3. 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:

1. Patients who are vital sign unstable and with severe complication.
2. Patients combined with other terminal illness such as cancer in terminal stage, liver failure, end stage renal failure and so on.
3. Pregnant patients.
4. Any other conditions deemed unsuitable by the physician in charge.
5. Patients (agent of the patient) who did not sign the consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group (Severe); 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; 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.
NO_INTERVENTION: Control group (Severe); 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); 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; 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.
NO_INTERVENTION: Control group (moderate); 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?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: wei Ling Chou, Chang Gung Medical Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2021
• Primary Completion (ANTICIPATED): June 7, 2024
• Study Completion (ANTICIPATED): June 7, 2024

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (ACTUAL): June 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: acupuncture; Traumatic brain injury, TBI; Bloodletting
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 202100683A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No