Tongyuan Acupuncture on Consciousness Disorder After Stroke

Last updated: March 19, 2024
Sponsor: Nanfang Hospital, Southern Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Acupuncture with regulating immunity as the core of treatment

Needles that are not on acupoints

Clinical Study ID

NCT06202833
NFEC-2023-464
  • Ages 18-85
  • All Genders

Study Summary

Stroke is a common and frequently-occurring disease in the world. Patients with stroke often have sequelae and functional disorders of varying degrees, among which the disturbance of consciousness has the greatest impact on prognosis and quality of life.At present, drug therapy, neurosurgical interventional therapy and modern physical therapy are mainly used for post-stroke consciousness disorders. The above therapies to improve the state of consciousness of patients are not supported by sufficient evidence-based evidence, and the other is that they have shortcomings, such as invasive, expensive, and strict indications. Acupuncture has been used in the treatment of sequelae of stroke for thousands of years in China. Tongyuan acupuncture is a set of traditional Chinese medicine therapy pioneered by Professor Lai Xinsheng, a famous doctor of Chinese medicine. A large number of previous studies have proved that Tongyuan acupuncture has a unique effect on the cardiovascular system, gynecology, ent, neurology and other functional disorders. In this study, Tongyuan acupuncture was used in patients with post-stroke consciousness disorder to observe its efficacy and explore the mechanism of action. The purpose of this study is to investigate whether Tongyuan acupuncture can improve the consciousness disorder after stroke, and to provide a new safe, effective, feasible and easy to popularize treatment method.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. sign the informed consent voluntarily;
  2. met the above diagnostic criteria, and the GCS score was between 3 and 9 (the scorewas scored by a rehabilitation physician, and the patient had not used sedatives oranesthetics on the day of the score);
  3. The patient's condition is stable, vital signs are stable, and the onset time ofconsciousness disturbance caused by stroke is confirmed to be less than 6 months;
  4. Cerebral infarction or cerebral hemorrhage confirmed by clinical and auxiliaryexamination is the only factor causing consciousness disorder, excluding otherdiseases caused consciousness disorder patients;
  5. those aged between 18 and 85;
  6. Family members or authorized principals know and sign informed consent;
  7. did not enter other clinical studies at the same time.

Exclusion

Exclusion Criteria:

  1. People with consciousness impairment mainly due to changes in consciousness content orspecial types;
  2. confirmed carbon monoxide poisoning, brain tumor, brain trauma, brain parasiticdisease, metabolic disorders;
  3. Patients with severe primary diseases of liver, kidney, blood system, endocrine systemand other diseases with poor prognosis, mental diseases;
  4. have upper gastrointestinal hemorrhage, secondary epilepsy and other seriouscomplications;
  5. Those who have venous thrombosis and are currently on anticoagulant therapy;
  6. patients judged by the investigator to be unsuitable for participation in this trial;

Study Design

Total Participants: 174
Treatment Group(s): 2
Primary Treatment: Acupuncture with regulating immunity as the core of treatment
Phase:
Study Start date:
March 20, 2024
Estimated Completion Date:
December 31, 2025

Study Description

This study was a randomized, placebo-controlled, single-blind study. Approximately 174 people will participate in the study at the medical facility. Patients with post-stroke consciousness disorder hospitalized in the Rehabilitation Department of Nanfang Hospital, Guangzhou, China, were randomly included into the experimental group and the control group, and the experimental group was treated with Tongyuan needle acupuncture on the basis of routine rehabilitation therapy and drug therapy. Experimental group selected points: baihui, zhongwan, guanyuan, qihai, tianshu (double).The control group was treated with 1cm acupuncture at the same depth beside the selected points of the experimental group. Before intervention, treatment for 1 week, treatment for 2 weeks, treatment for 3 weeks, and treatment for 4 weeks (after completion), follow-up: Glasgow coma score, Modified Coma Recovery Scale（CRS-R scale） were performed 4 weeks after discharge to assess the conscious state of the patients, and electroencephalogram（EEG）, brainstem evoked potential and Encephalofluctuography were examined before intervention and 4 weeks after treatment. The baseline data of the experimental group and the control group showed no statistical difference through statistical analysis. Conventional rehabilitation treatment and drug treatment were adopted by the current guidelines, and the distribution of cases in the two groups was also random.

Connect with a study center

  • YI WEI

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

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