Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04930146
Other study ID # 202100683A3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 8, 2021
Est. completion date June 7, 2024

Study information

Verified date June 2021
Source Chang Gung Memorial Hospital
Contact wei Ling Chou
Phone +886 975360906
Email wenni1207@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date June 7, 2024
Est. primary completion date June 7, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary GCS(Glasgow Coma Scale) To assess the recovery of consciousness. Lower GCS scores are correlated with higher risk of death. 4 weeks
Primary Barthel index To assess the activities of daily life. 4 weeks
Primary Muscle power To assess the recovery of muscle power. 4 weeks
Primary mGOS(Modified Glasgow Outcome Score) To assess the neurological outcomes, score 1 to 5. the higher the score, the better outcome. 4 weeks
Primary 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 Meridian energy assessment To assess meridian energy by Meridian Energy Analysis Device (M.E.A.D. ) 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT02878577 - Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury
Active, not recruiting NCT02918994 - LearningRx Cognitive Training for TBI N/A
Completed NCT02524067 - Modified Environment for Agitation in Patients With TBI N/A
Completed NCT01760785 - Valproate for Mood Swings and Alcohol Use Following Head Injury N/A
Recruiting NCT05033444 - A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers Phase 1
Not yet recruiting NCT04003285 - Allopregnanolone in Chronic Complex Traumatic Brain Injury Phase 2
Completed NCT01750268 - Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI Phase 4
Recruiting NCT01512524 - Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury N/A
Completed NCT04796207 - The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes N/A
Completed NCT02657135 - Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury N/A
Completed NCT01956136 - Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury N/A
Withdrawn NCT02356861 - LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans N/A
Not yet recruiting NCT05675423 - Imaging Characterization of the Biomechanical Coupling of Brain and Skull
Withdrawn NCT01891383 - Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel
Withdrawn NCT01779427 - Attention Intervention Management N/A
Completed NCT02764983 - Occupational Therapy Driving Intervention for Returning Combat Veterans. N/A
Completed NCT01118195 - Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans N/A
Completed NCT01547780 - Translocator Protein and Inflammation After Traumatic Brain Injury Phase 1/Phase 2
Recruiting NCT03874208 - Prediction for Coma Recovery With Comaweb N/A
Completed NCT03314584 - Managing MTBI-related Headaches With rTMS N/A