Tongyuan Acupuncture on Consciousness Disorder After Stroke

NCT06202833 | Recruiting DMC

• 1 other identifier: NFEC-2023-464
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Strokes; Acupuncture; Consciousness Disorder

Outcome Measures

Primary Outcomes (1)

• gcs score

  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.

  4 weeks

Secondary Outcomes (1)

• CRS-R Scale

  4 weeks

Other Outcomes (3)

• electroencephalograph，EEG

  4 weeks

• Brainstem Auditory Evoked Potential，BAEP

  4 weeks

• Encephalofluctuography，EFG

  4 weeks

Study Arms (2)

Tongyuan acupuncture

EXPERIMENTAL

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.

Device: Acupuncture with regulating immunity as the core of treatment

Sham acupoint acupuncture

SHAM COMPARATOR

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.

Device: Needles that are not on acupoints

Interventions

Acupuncture with regulating immunity as the core of treatment DEVICE

The patient was supine, the acupuncture points were disinfected with 75% ethanol, and the acupuncture points on the head and neck were first acupuncture, and then the acupuncture points on the abdomen and limbs. baihui: When the 1.5 inch millimeter needle is needled, the tip of the needle and the acupoint are at a 15-30 ° Angle, and the needle is about 1 inch flat along the subcutaneous area. The twisting speed is about 200 times per minute, and the stitches are once every 15 minutes, and each stitch is about 30 seconds. zhongwan, tianshu: 1.5 inch needle straight puncture 1 inch, small amplitude lifting and twisting. guanyuan, qihai: 1.5 inch millimeter needle downward oblique puncture 1 inch, small amplitude lifting and twisting. The above acupoints were measured by obtaining qi, and the needles were retained for 30min, once a day.5 days a week for 4 weeks.Twenty days in total.

Also known as: Tongyuan acupoint acupuncture

Tongyuan acupuncture

Needles that are not on acupoints DEVICE

In this group, acupuncture treatment was performed at 1cm side of the selected points of the Tongyuan acupoint acupuncture group.The piercing Angle is the same as the test group, only piercing, not twisting.Once a day, 5 days a week for 4 weeks.Twenty days in total.

Also known as: Sham acupoint acupuncture

Sham acupoint acupuncture

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sign the informed consent voluntarily;
• 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);
• 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;
• 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;
• those aged between 18 and 85;
• Family members or authorized principals know and sign informed consent;
• did not enter other clinical studies at the same time.

You may not qualify if:

• People with consciousness impairment mainly due to changes in consciousness content or special types;
• confirmed carbon monoxide poisoning, brain tumor, brain trauma, brain parasitic disease, metabolic disorders;
• Patients with severe primary diseases of liver, kidney, blood system, endocrine system and other diseases with poor prognosis, mental diseases;
• have upper gastrointestinal hemorrhage, secondary epilepsy and other serious complications;
• Those who have venous thrombosis and are currently on anticoagulant therapy;
• patients judged by the investigator to be unsuitable for participation in this trial;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

YI WEI

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Stroke; Consciousness Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• YI WEI

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YI WEI

CONTACT

18588528868; 371328658@qq.com

YINGMIN JIAN

CONTACT

13631458025; 718208473@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blind for patients, blind for data processing personnel, not blind for acupuncture operators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: January 12, 2024
• Study Start: March 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CN (1)