Tongyuan Acupuncture on Consciousness Disorder After Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Needles that are not on acupoints; Device: Acupuncture with regulating immunity as the core of treatment

• Registration Number: NCT06202833
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2024-01-09
• Study First Posted: 2024-01-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Study Start: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

1. sign the informed consent voluntarily;
2. met the above diagnostic criteria, and the GCS score was between 3 and 9 (the score was scored by a rehabilitation physician, and the patient had not used sedatives or anesthetics on the day of the score);
3. The patient's condition is stable, vital signs are stable, and the onset time of consciousness disturbance caused by stroke is confirmed to be less than 6 months;
4. Cerebral infarction or cerebral hemorrhage confirmed by clinical and auxiliary examination is the only factor causing consciousness disorder, excluding other diseases 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 Criteria

1. People with consciousness impairment mainly due to changes in consciousness content or special types;
2. confirmed carbon monoxide poisoning, brain tumor, brain trauma, brain parasitic disease, metabolic disorders;
3. Patients with severe primary diseases of liver, kidney, blood system, endocrine system and other diseases with poor prognosis, mental diseases;
4. have upper gastrointestinal hemorrhage, secondary epilepsy and other serious complications;
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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham acupoint acupuncture	Needles that are not on acupoints	In the sham-acupoint group, acupuncture treatment was carried out 1cm beside the selected points of the experimental group, once a day, 5 days a week, for 4 consecutive weeks. Twenty days in total. Consciousness levels were assessed before intervention, at 1, 2, 3, and 4 weeks of treatment, and 4 weeks after discharge.
Tongyuan acupuncture	Acupuncture with regulating immunity as the core of treatment	Point selection of Tongyuan acupuncture group: baihui, zhongwan, guanyuan, qihai, tianshu (double).The method of lifting, inserting and twisting was used once a day, 5 days a week for 4 consecutive weeks. Twenty days in total. Consciousness levels were assessed before intervention, at 1, 2, 3, and 4 weeks of treatment, and 4 weeks after discharge.

Primary Outcome Measures

Name	Time	Method
gcs score	4 weeks	The Glasgow coma scale has a minimum of 3 and a maximum of 15, with higher scores representing better consciousness.Valid criteria for GCS score: Consciousness improvement rate of each patient = (GCS score after treatment - GCS score before treatment)/GCS score before treatment ×100% Consciousness improvement rate ≥20% is effective, 15%≤ consciousness improvement rate \< 20% is effective, and consciousness improvement rate \< 15% is ineffective.

Secondary Outcome Measures

Name	Time	Method
CRS-R Scale	4 weeks	the Coma Recovery Scale - Revised, CRS-R, with a minimum value of 0 and a maximum value of 23, the higher the score, the better the state of consciousness.Valid CRS-R scoring criteria: The minimum state of consciousness (MCS) was assessed as: visual \> 1 or auditory \> 2 or verbal response \> 2 or motor \> 2 or communication \> 0 or arousal \> 2; The evaluation criteria of persistent vegetative state (VS) were: vision ≤1 score, hearing ≤2 score, speech response ≤2 score, movement ≤2 score, communication = 0 score and arousal ≤2 score; Clarity of mind was assessed on a scale of exercise = 6 points or communication = 2 points.; A change from below MCS to MCS, or from MCS to VS, or from VS to clear consciousness, or an increase of one level or more in the state of consciousness is considered valid.; Meeting the GCS score or CRS-R score validity criteria can be considered valid.

Trial Locations

Locations (1)

YI WEI; 🇨🇳 Guangzhou, Guangdong, China