Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage

Investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Hemorrhages
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Sham Acupuncture(Superficial Acupuncture)

Detailed Description

Stroke is a major cause of death and disability. According to the Ministry of Health and Welfare in Taiwan, stroke accounted for 6.8% of all deaths and was the 4th leading cause of death in Taiwan in 2020. Stroke can be divided into acute, subacute, and chronic stages, and the initial severity of stroke affects recovery from sequelae. Therefore, how to effectively improve the sequelae and accelerate the recovery of patients through early interventions is an important issue. This study aimed to investigate the effect of early acupuncture treatment in the acute stage of hemorrhagic stroke. Subjects will be divided into two main groups by random assignment. The intervention group will be treated with traditional acupuncture, while the control group will be treated with pseudo-acupuncture(superficial acupuncture). The treatment frequency was 3 times a week for at least one week. Consciousness, neurological status and disability status were assessed before treatment, at the end of the first week, the second week and the third week, and biomarker were examined before and after treatment

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Ru Ko; Phone Number: 886972792003; Email: b9403213@cgmh.org.tw

Study Locations

• Taiwan
  • Keelung, Taiwan
    • Recruiting
    • Chang-Gung Memorial Hospital
    • Contact: Yan Ru Ko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of hemorrhagic stroke by a specialist
• Age over 20 years and below 85 years
• GCS between 5-13

Exclusion Criteria:

• Intracranial hemorrhage resulted from vascular anomalies
• Pregnant patients
• Intracranial tumor related hemorrhage
• Other diseases that can cause neurological deficits, such as old cerebrovascular disease, poliomyelitis, cerebral palsy, spinal cord injury
• Organ damage or terminal illness (heart or kidney failure or malignancy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group(acupuncture group); After blind random allocation, investigators applied acupuncture on patient with acute intracranial hemorrhage.	Procedure: Acupuncture; Applied acupuncture on specific acupoints in patient with acute intracranial hemorrhage.
Placebo Comparator: Control group(sham acupuncture group (superficial acupuncture)); After blind random allocation, investigators applied superficial acupuncture on patient with acute intracranial hemorrhage.	Procedure: Sham Acupuncture(Superficial Acupuncture); Applied superficial acupuncture on specific acupoints in patient with acute intracranial hemorrhage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index	The Barthel Index is a scale used to measure performance in activities of daily living (ADL). The total score can range from 0 (complete dependence) to 100 (complete independence), providing a quantitative measure of an individual's functional independence.	3 weeks and follow-up for one year
Muscle Power	Muscle power is often assessed using a grading system. The most common is the Medical Research Council (MRC) Scale, which grades muscle strength on a scale from 0 to 5 and the lower scores mean the worse outcome.	3 weeks and follow-up for one year
The Modified Rankin Scale	The Modified Rankin Score (mRS) is a scale with scores ranging from 0 to 6, the higher scores mean the worse outcome.	3 weeks and follow-up for one year
National Institute of Health Stroke Scale	The total NIHSS score can range from 0 to 42, where a score of 0 means no stroke symptoms, and a higher score indicates a more severe stroke.	3 weeks and follow-up for one year
Glasgow Coma Scale(GCS)	The Glasgow Coma Scale(GCS) is a clinical scale used to reliably measure a person's level of consciousness. The total score can range from 3 to 15, and the lower scores mean the worse outcome.	3 weeks and follow-up for one year
Karnofsky Performance Scale	The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death.	3 weeks and follow-up for one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse analysis system (PPAS-96)(Sphygmography)	Pulse analysis system (PPAS-96) can realize the digitization of pulse wave graphics, establish a pulse wave database (scale unit: Hertz, Hz).	3 weeks and follow-up for one year
Completed blood count (CBC)	Measuring the amounts of red blood cells (RBC, million/μL), white blood cells (WBC, 1000/μL), platelets (Plt, 1000/μL), along with the hemoglobin (Hb, g/dL) and hematocrit (Hct, %) values via automated hematology analyzer.	3 weeks and follow-up for one year
White blood cells differential count	Calculating the percentage of each type of white blood cell (WBC): Segment(%), Band(%), Lymphocyte(%), Monocyte(%), Eosinophil(%), Basophil(%)	3 weeks and follow-up for one year
C reactive protein (CRP)	Measuring the level of C reactive protein in blood. (CRP, mg/L)	3 weeks and follow-up for one year
Albumin	Measuring the level of albumin in blood. (Alb, g/dL)	3 weeks and follow-up for one year
Blood urea nitrogen (BUN)	Measuring the level of blood urea nitrogen. (BUN, mg/dL)	3 weeks and follow-up for one year
Creatinine	Measuring the level of creatinine in blood. (Crea, mg/dL)	3 weeks and follow-up for one year
Sodium	Measuring the level of sodium in blood. (Na, milliequivalent (mEq)/L)	3 weeks and follow-up for one year
Potassium	Measuring the level of potassium in blood. (K, milliequivalent (mEq)/L)	3 weeks and follow-up for one year

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Yan Ru Ko, Chang Gung memorial hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Intracranial Hemorrhages
• Other Study ID Numbers: 202201836A3

Drug and device information, study documents

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