Clinical trial NCT06202833: Tongyuan Acupuncture on Consciousness Disorder After Stroke
Official title: Study on the Effect of Tongyuan Acupuncture on Consciousness Disorder After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Strokes
Acupuncture
Consciousness Disorder
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For stroke patients with consciousness disturbance, the Glasgow coma score was between 3 and 9 points, the patient's vital signs were stable, and the onset time of consciousness disturbance caused by stroke was confirmed to be less than 6 months; Clinical and auxiliary examination confirmed that cerebral infarction or cerebral hemorrhage is the only factor causing consciousness disorder, excluding other diseases caused consciousness disorder patients; Aged between 18 and 85 years old; Family members or authorized clients are informed and sign informed consent; Did not enter other clinical studies at the same time.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: gcs score
timeFrame: 4 weeks
Secondary outcomes:
measure: CRS-R Scale
timeFrame: 4 weeks
Other outcomes:
measure: electroencephalograph，EEG
timeFrame: 4 weeks
measure: Brainstem Auditory Evoked Potential，BAEP
timeFrame: 4 weeks
measure: Encephalofluctuography，EFG
timeFrame: 4 weeks
Locations:
city: Guangzhou
country: China
facility: YI WEI
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: YI WEI
role: PRINCIPAL_INVESTIGATOR
References: