AcupunctureHEALTHNCT05561088
Efficacy and Safety of Head Acupuncture After Mechanical Thrombectomy for Acute Ischemic Stroke
A study testing Scalp Acupuncture and The treatment recommended in the guidelines for acute ischemic stroke was administered in people with Acupuncture and Acute Ischemic Stroke, run by Xi'an No.3 Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of head acupuncture combined with endovascular therapy for cerebral infarction compared with endovascular therapy alone Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acupuncture, Acute Ischemic Stroke, Mechanical Thrombectomy
- What is being tested?
- Scalp Acupuncture and The treatment recommended in the guidelines for acute ischemic stroke was administered
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2023to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Patients with acute ischemic stroke who received endovascular treatment within 24 hours of onset;
- 6 < NIHSS ≤25;
- ASPECT score ≥6 points;
- Signed Informed consent.
Who cannot join
- CT or brain MRI confirmed intracranial tumor and intracranial hemorrhage;
- Contraindications of contrast media;
- Dementia or mental illness，unable to cooperate with treatment and follow-up;
- The expected survival time was less than 3 months;
- Women who are pregnant, planning to become pregnant or breastfeeding;
- Currently participating in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xi 'an No.3 Hospital
Xi'an, Shaanxi, 710018
Shilin Li, Doctor, 8615398076154, lihuashiling@126.com
Mingze Chang, Doctor, 8615609250698, changmingze191@163.com
About this study
Official title: A Single-center, Prospective, Randomized, Controlled Study of Mechanical Thrombectomy Followed by Acupuncture for Acute Ischemic Stroke
To evaluate the efficacy and safety of head acupuncture combined with endovascular therapy for cerebral infarction compared with endovascular therapy alone
Read the detailed description
Control group: Mechanical thrombectomy followed by the guideline recommended treatment for acute ischemic stroke;
Experimental group: After mechanical thrombectomy, head acupuncture and the treatment regimen recommended by the guideline for acute ischemic stroke were administered
- Conditions
- Acupuncture, Acute Ischemic Stroke, Mechanical Thrombectomy
- Being tested
- Scalp Acupuncture, The treatment recommended in the guidelines for acute ischemic stroke was administered
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp AcupunctureOther
mplementation plan of head needle: The middle frontal line (MS1), the middle parietal line (MS5) and the back parietal and temporal oblique line (MS7) in the International Standardization Program for the Name of the first needle Point in 1989 were selected, and the needles were inserted along the shape of each section. One needle was inserted into the middle frontal line and the middle parietal line, and two needles were inserted into the back parietal and temporal oblique line. The KWD-808I pulse electrotherapy instrument produced by Changzhou Wujin Great Wall Medical Equipment Co., Ltd. is used on the needle handle after lifting, inserting and twisting. The continuous waveform was used, the voltage was 2-4 V, the frequency was 60-80 times /min, the intensity was tolerated by the patient, the needle was kept for 30min, and the treatment was performed once a day.
The treatment recommended in the guidelines for acute ischemic stroke was administeredOther
The treatment recommended in the guidelines for acute ischemic stroke was administered
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Mechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment Receives: Other: Scalp Acupuncture; Other: The treatment recommended in the guidelines for acute ischemic stroke was administered |
| control group | Experimental | Conventional treatment based on guidelines was administered after mechanical thrombectomy Receives: Other: The treatment recommended in the guidelines for acute ischemic stroke was administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Modified rankin scale (mRS) score ≤2
The modified rankin Scale (mRS) score ≤2 indicates that the patient has the ability to live independently.
Measured: 90 days after onset
Secondary outcomes (3)
National Institute of Health stroke scale(NIHSS) score
NIHSS scores range from 0 to 42, with higher scores indicating more severe nerve damage.
Measured: 10 days after onset
Modified rankin scale (mRS) score
Modified rankin scale (mRS) Score is used to measure the neurological function recovery status of patients after stroke, and its score ranges from 0 to 6
Measured: 90 days after onset
Incidence of cerebral hemorrhage
No hemorrhage was found on the first head CT/MRI after cerebral infarction, but intracranial hemorrhage was found on the second head CT/MRI
Measured: 7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start27 Apr 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an No.3 Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561088
- Sponsor's protocol ID
- sy-11-2022-124
- Acronym
- HEALTH
- Status last verified
- May 2023
- First submitted
- 27 Sep 2022
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Randomized, Controlled Study of Mechanical Thrombectomy Followed by Acupuncture for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05561088
- Acronym / sponsor ID
- HEALTH / sy-11-2022-124
- Conditions
- Acupuncture, Acute Ischemic Stroke, Mechanical Thrombectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Xi'an No.3 HospitalOther government
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 30 Sep 2022 (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.
To evaluate the efficacy and safety of head acupuncture combined with endovascular therapy for cerebral infarction compared with endovascular therapy alone
Detailed description
Control group: Mechanical thrombectomy followed by the guideline recommended treatment for acute ischemic stroke;
Experimental group: After mechanical thrombectomy, head acupuncture and the treatment regimen recommended by the guideline for acute ischemic stroke were administered
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Scalp Acupuncture, Other: The treatment recommended in the guidelines for acute ischemic stroke was administeredMechanical thrombectomy was followed by acupuncture and guideline-based conventional treatment |
| control group | Experimental | Other: The treatment recommended in the guidelines for acute ischemic stroke was administeredConventional treatment based on guidelines was administered after mechanical thrombectomy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Patients with acute ischemic stroke who received endovascular treatment within 24 hours of onset;
- 6 < NIHSS ≤25;
- ASPECT score ≥6 points;
- Signed Informed consent.
Key exclusion criteria (6 listed)
- CT or brain MRI confirmed intracranial tumor and intracranial hemorrhage;
- Contraindications of contrast media;
- Dementia or mental illness，unable to cooperate with treatment and follow-up;
- The expected survival time was less than 3 months;
- Women who are pregnant, planning to become pregnant or breastfeeding;
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 |
|---|---|---|
| Scalp Acupuncturemplementation plan of head needle: The middle frontal line (MS1), the middle parietal line (MS5) and the back parietal and temporal oblique line (MS7) in the International Standardization Program for the Name of the first needle Point in 1989 were selected, and the needles were inserted along the shape of each section. One needle was inserted into the middle frontal line and the middle parietal line, and two needles were inserted into the back parietal and temporal oblique line. The KWD-808I pulse electrotherapy instrument produced by Changzhou Wujin Great Wall Medical Equipment Co., Ltd. is used on the needle handle after lifting, inserting and twisting. The continuous waveform was used, the voltage was 2-4 V, the frequency was 60-80 times /min, the intensity was tolerated by the patient, the needle was kept for 30min, and the treatment was performed once a day. | Other | experimental group |
| The treatment recommended in the guidelines for acute ischemic stroke was administeredThe treatment recommended in the guidelines for acute ischemic stroke was administered | Other | control group, experimental group |
Primary outcome
Ratio of Modified rankin scale (mRS) score ≤2
Time frame: 90 days after onset
The modified rankin Scale (mRS) score ≤2 indicates that the patient has the ability to live independently.
3 secondary outcomes
National Institute of Health stroke scale(NIHSS) score
Time frame: 10 days after onset
Modified rankin scale (mRS) score
Time frame: 90 days after onset
Incidence of cerebral hemorrhage
Time frame: 7 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalp Acupuncture and The treatment recommended in the guidelines for acute ischemic stroke was administered in people with Acupuncture and Acute Ischemic Stroke, run by Xi'an No.3 Hospital 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 5 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: looking for participants now, as of the sponsor's last update on 12 May 2023. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shilin L i, Doctor (8615398076154, lihuashiling@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of Modified rankin scale (mRS) score ≤2 (time frame: 90 days after onset). 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 12 May 2023.