StrokeTAOCDASNCT06202833
Tongyuan Acupuncture on Consciousness Disorder After Stroke
A study testing Acupuncture with regulating immunity as the core of treatment and Needles that are not on acupoints in people with Stroke, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Acupuncture with regulating immunity as the core of treatment and Needles that are not on acupoints
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
YI WEI
Guangzhou, Guangdong, 510515
YI WEI, 18588528868, 371328658@qq.com
YINGMIN JIAN, 13631458025, 718208473@qq.com
About this study
Official title: Study on the Effect of Tongyuan Acupuncture on Consciousness Disorder After Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Acupuncture with regulating immunity as the core of treatment, Needles that are not on acupoints
- Keywords
- Strokes, Acupuncture, Consciousness Disorder
- Medical subject headings
- Stroke, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture with regulating immunity as the core of treatmentDevice
Also called Tongyuan acupoint acupuncture
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.
Needles that are not on acupointsDevice
Also called Sham acupoint acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Needles that are not on acupoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
CRS-R Scale
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start20 Mar 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YI WEI, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202833
- Sponsor's protocol ID
- NFEC-2023-464
- Acronym
- TAOCDAS
- Status last verified
- Mar 2024
- First submitted
- 3 Dec 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Tongyuan Acupuncture on Consciousness Disorder After Stroke
- ClinicalTrials.gov ID
- NCT06202833
- Acronym / sponsor ID
- TAOCDAS / NFEC-2023-464
- Conditions
- Stroke
- Keywords
- Strokes, Acupuncture, Consciousness Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tongyuan acupuncture | Experimental | Device: Acupuncture with regulating immunity as the core of treatmentPoint 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. |
| Sham acupoint acupuncture | Sham comparator | Device: Needles that are not on acupointsIn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture with regulating immunity as the core of treatmentAlso: Tongyuan acupoint acupunctureThe 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. | Device | Tongyuan acupuncture |
| Needles that are not on acupointsAlso: Sham acupoint acupunctureIn 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. | Device | Sham acupoint acupuncture |
Primary outcome
gcs score
Time frame: 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.
1 secondary outcome
CRS-R Scale
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YI WEI principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture with regulating immunity as the core of treatment and Needles that are not on acupoints in people with Stroke, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YI WEI (18588528868, 371328658@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gcs score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.