Post-stroke Mild Cognitive ImpairmentNCT05924308
Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial
A study testing electroacupuncture in people with Post-stroke Mild Cognitive Impairment, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
1. On the basis of previous studies, standardized randomized controlled clinical trials were conducted to observe the efficacy and safety of acupuncture in the treatment of mild cognitive impairment after stroke using the international rating scale, and the clinical experience was transformed into evidence. 2. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Post-stroke Mild Cognitive Impairment
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 May 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting the diagnostic criteria: ① Stroke diagnostic criteria: according to the diagnostic criteria of cerebral infarction and cerebral hemorrhage in the "Chinese Guidelines for the Prevention and Treatment of Stroke (2021 edition)" issued by the National Health Commission, the diagnosis was confirmed by head CT or MRI examination. ② Mild cognitive impairment diagnostic criteria: according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and cognitive Impairment (5) : Diagnosis and treatment of mild cognitive Impairment. ③ TCM diagnostic criteria: according to the "TCM Diagnostic Efficacy Criteria" issued by the State Administration of Traditional Chinese Medicine in 2012, the patients were diagnosed as dementia.
- 40 years old ≤ age ≤75 years old, regardless of gender;
- cognitive impairment occurred after stroke without other causes;
- cognitive impairment within 6 months after stroke;
- stable condition, clear consciousness, MoCA score < 26 points;
- those who were willing to participate in the study and signed the "informed consent".
Who cannot join
- Brain CT or MRI showed other lesions unrelated to stroke, or severe brain atrophy or leukoaraiosis; (2) serious complications (myocardial infarction, heart failure, malignant tumor, severe infection, mental illness, severe depression, epilepsy, etc.);
- with obvious hearing impairment, visual impairment, aphasia and other inability to cooperate in the physical evaluation; (4) pregnant or intended to pregnant women, lactating women; ⑤ intolerance to acupuncture; ⑥ bleeding tendency and poor coagulation function.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital, Shanghai university of TCM
Shanghai, Shanghai Municipality, 200031
Jia Xu, Doctor, +86 13564350018, hotohorij@126.com
About this study
- On the basis of previous studies, standardized randomized controlled clinical trials were conducted to observe the efficacy and safety of acupuncture in the treatment of mild cognitive impairment after stroke using the international rating scale, and the clinical experience was transformed into evidence.
- According to the clinical outcomes reported by patients, the differences between Chinese and western scales in evaluating mild cognitive impairment after stroke were compared. On the basis of "disease differentiation, syndrome differentiation and meridian differentiation", the syndrome differentiation and treatment system of mild cognitive impairment after stroke was preliminarily constructed, and the TCM syndrome prediction model was improved.
- Conditions
- Post-stroke Mild Cognitive Impairment
- Being tested
- electroacupuncture, sham acupuncture
- Keywords
- Acupuncture therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
every time 30 min, 1 times a day, five times a week, 4 weeks for 1 course of treatment, treatment 3 period of treatment.
sham acupunctureOther
Electroacupuncture was connected to the fixed place of Sishencong on the left and right sides of Baihui and Shenting, and the electroacupuncture instrument was returned to zero. Pull out the needle when informed patient for cotton on the above points, to make patients feel the needle was pulled out. The same treatment time of 30 min, 1 times a day, five times a week, 4 weeks for 1 course of treatment, treatment 3 period of treatment.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | Not described Receives: Other: sham acupuncture |
| treatment group | Experimental | Not described Receives: Other: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
Mini-mental State Examination scale
Measured: week (0,4,8,12,20)
Secondary outcomes (4)
MoCA
Montreal Cognitive Assessment
Measured: week (0,4,8,12,20)
MBI
Modified Barthel Index
Measured: week (0,4,8,12,20)
SSTCM
Measured: week (0,4,8,12,20)
SS-QOL
Measured: week (0,4,8,12,20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Sep 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Mild Cognitive ImpairmentStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924308
- Sponsor's protocol ID
- YD202219
- Status last verified
- Sep 2022
- First submitted
- 20 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05924308
- Acronym / sponsor ID
- YD202219
- Conditions
- Post-stroke Mild Cognitive Impairment
- Keywords
- Acupuncture therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 29 Jun 2023 (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.
- On the basis of previous studies, standardized randomized controlled clinical trials were conducted to observe the efficacy and safety of acupuncture in the treatment of mild cognitive impairment after stroke using the international rating scale, and the clinical experience was transformed into evidence.
- According to the clinical outcomes reported by patients, the differences between Chinese and western scales in evaluating mild cognitive impairment after stroke were compared. On the basis of "disease differentiation, syndrome differentiation and meridian differentiation", the syndrome differentiation and treatment system of mild cognitive impairment after stroke was preliminarily constructed, and the TCM syndrome prediction model was improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Other: sham acupuncture |
| treatment group | Experimental | Other: electroacupuncture |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meeting the diagnostic criteria: ① Stroke diagnostic criteria: according to the diagnostic criteria of cerebral infarction and cerebral hemorrhage in the "Chinese Guidelines for the Prevention and Treatment of Stroke (2021 edition)" issued by the National Health Commission, the diagnosis was confirmed by head CT or MRI examination. ② Mild cognitive impairment diagnostic criteria: according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and cognitive Impairment (5) : Diagnosis and treatment of mild cognitive Impairment. ③ TCM diagnostic criteria: according to the "TCM Diagnostic Efficacy Criteria" issued by the State Administration of Traditional Chinese Medicine in 2012, the patients were diagnosed as dementia.
- 40 years old ≤ age ≤75 years old, regardless of gender;
- cognitive impairment occurred after stroke without other causes;
- cognitive impairment within 6 months after stroke;
- stable condition, clear consciousness, MoCA score < 26 points;
Key exclusion criteria (2 listed)
- Brain CT or MRI showed other lesions unrelated to stroke, or severe brain atrophy or leukoaraiosis; (2) serious complications (myocardial infarction, heart failure, malignant tumor, severe infection, mental illness, severe depression, epilepsy, etc.);
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 |
|---|---|---|
| electroacupunctureevery time 30 min, 1 times a day, five times a week, 4 weeks for 1 course of treatment, treatment 3 period of treatment. | Other | treatment group |
| sham acupunctureElectroacupuncture was connected to the fixed place of Sishencong on the left and right sides of Baihui and Shenting, and the electroacupuncture instrument was returned to zero. Pull out the needle when informed patient for cotton on the above points, to make patients feel the needle was pulled out. The same treatment time of 30 min, 1 times a day, five times a week, 4 weeks for 1 course of treatment, treatment 3 period of treatment. | Other | control group |
Primary outcome
MMSE
Time frame: week (0,4,8,12,20)
Mini-mental State Examination scale
4 secondary outcomes
MoCA
Time frame: week (0,4,8,12,20)
MBI
Time frame: week (0,4,8,12,20)
SSTCM
Time frame: week (0,4,8,12,20)
SS-QOL
Time frame: week (0,4,8,12,20)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Post-stroke Mild Cognitive Impairment, run by Shanghai University of Traditional Chinese Medicine 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 6 inclusion and 2 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 29 Jun 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. 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 Jia Xu, Doctor (+86 13564350018, hotohorij@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (time frame: week (0,4,8,12,20)). 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 29 Jun 2023.