Acupuncture treatment for consciousness disorders after stroke

Study on the Effect of Tongyuan Acupuncture on Consciousness Disorder After Stroke

This study is testing whether Tongyuan acupuncture can help improve awareness in stroke patients who have consciousness disorders.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06202833 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of Tongyuan acupuncture on patients with consciousness disorders following a stroke. It is a randomized, placebo-controlled, single-blind trial involving approximately 174 participants who will receive either Tongyuan acupuncture or a placebo treatment alongside standard rehabilitation and drug therapy. The study aims to assess changes in consciousness levels using various scales and neurological assessments over a four-week period. The acupuncture points targeted in the experimental group are specifically chosen to enhance treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with stable vital signs and a Glasgow Coma Scale score between 3 and 9 due to consciousness disturbances from a stroke occurring within the last six months.

Not a fit: Patients whose consciousness impairment is primarily due to conditions other than stroke, such as brain tumors or carbon monoxide poisoning, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the consciousness and quality of life for stroke patients suffering from consciousness disorders.

How similar studies have performed: Previous studies have shown promising results for acupuncture in treating stroke sequelae, but this specific approach with Tongyuan acupuncture is relatively novel.

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;

Where this trial is running

Guangzhou, Guangdong

• Yi Wei — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Yi Wei — Nanfang Hospital, Southern Medical University
• Study coordinator: Yi Wei

Conditions Stroke; Strokes; Acupuncture; Consciousness Disorder