Scalp Acupuncture for Dyskinesia After Ischemic Stroke (LUSA)
Primary Purpose
Ischemic Stroke
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Scalp acupuncture
Conventional rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
Meet to criteria for diagnosis and efficacy evaluation of stroke, formulated by The State Administration of Traditional Chinese Medicine Encephalopathy Emergency Cooperative Group in 1996 (trial implementation)
- Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China in 2014 (Neurology Branch of Chinese Medical Association and Cerebrovascular Disease Association of Neurology Branch of Chinese Medical Association, 2015)
- Ischemic stroke diagnosed by CT or magnetic resonance imaging (MRI), with the presence of stable vital signs and awareness
- An age of 40-70 years Onset within 1-6 months
- Motor dysfunction in the extremities
- A Mini-Mental State Examination (Pangman et al., 2000) score > 24 points
Exclusion Criteria:
Consciousness disorder or severe cognitive impairment
- Severe Parkinson's disease, heart disease, cancer, epilepsy, or chronic alcoholism
- Hepatic or renal impairment
- Hemorrhagic tendency
- Sensitivity to acupuncture
- Congenital disability
- Pregnancy
- Currently participating in other clinical trials
Sites / Locations
- Longhua Hospital, Shanghai University of Traditional Chinese Medicine
- Longhua hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Scalp acupuncture
Conventional rehabilitation
Arm Description
number:58 The needle will be maintained in place for 30 minutes. Patients in both groups will receive rehabilitation five times per week (Monday through Friday) for 8 consecutive weeks.
number:58 Rehabilitation will be conducted for 1 hour five times per week (Monday through Friday) for 8 weeks.
Outcomes
Primary Outcome Measures
The Fugl-Meyer Assessment (FMA)
Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.
Secondary Outcome Measures
The Fugl-Meyer Assessment (FMA)
Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.
modified Barthel Index (mBI)
to evaluate the daily life function, including stool, urine, dressing, using the toilet, eating, transfer, walking for 45 meters, wearing clothes, going up and down stairs, and bathing.
Stroke syndrome of traditional Chinese medicine (SSTCM)
self-rating scale that reflects the quality of life of stroke patients
fractional amplitude of low frequency fluctuation (fALFF)
fALFF aquired by fMRI technique measures the relative contribution of low frequency fluctuations within a specific frequency band to the whole detectable frequencyrange
Full Information
NCT ID
NCT03120650
First Posted
April 11, 2017
Last Updated
September 5, 2022
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT03120650
Brief Title
Scalp Acupuncture for Dyskinesia After Ischemic Stroke
Acronym
LUSA
Official Title
Scalp Acupuncture for Dyskinesia After Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
March 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern theories in medical anatomy has been widely used to treat ischemic stroke in China, but effective clinical trials that verify its efficacy are lacking. This study proposes to verify the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential improvement of motor function between conventional rehabilitation alone and conventional rehabilitation with Lu's scalp acupuncture.
Detailed Description
A randomized, controlled, parallel, clinical trial. 116 ischemic stroke patients will be collected with dyskinesia from Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Huashan Hospital, Fudan University in China. All patients will be equally randomized into either a control group (conventional rehabilitation) or an experimental group (scalp acupuncture + conventional rehabilitation). In the control group, patients will receive conventional rehabilitation according to the Guidelines for Stroke Rehabilitation in China. In the experimental group, conventional rehabilitation will be supplemented with oblique acupuncture at approximately 15° and an insertion depth of 25-35 mm in the motor areas of the scalp. Twisting speed will be 200 times per minute. Acupuncture will be performed six times per day in 1-minute bouts, with a 4-minute rest following each bout. Patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks. The primary outcome will be the difference in Fugl-Meyer motor function score between posttreatment (4 weeks, 8 weeks, and 6 months of follow-up) and baseline.
The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scalp acupuncture
Arm Type
Experimental
Arm Description
number:58 The needle will be maintained in place for 30 minutes. Patients in both groups will receive rehabilitation five times per week (Monday through Friday) for 8 consecutive weeks.
Arm Title
Conventional rehabilitation
Arm Type
Active Comparator
Arm Description
number:58 Rehabilitation will be conducted for 1 hour five times per week (Monday through Friday) for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Scalp acupuncture
Intervention Description
Acupoint selection: Shenting (DU24; Baihui (DU20; and upper 1/5 and middle 2/5 in the contralateral motor area (upper: 0.5 cm posterior to the midpoint of the front and rear midline; middle 2/5: intersection between the eyebrow line and the leading edge of the temple hairline.
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
Rehabilitation plans will be made according to the Guidelines for Stroke Rehabilitation in China (Cerebrovascular Disease Association and the Neurological Rehabilitation Association of Neurology Branch of the Chinese Medical Association, 2012), including physical therapy and occupational therapy.
Primary Outcome Measure Information:
Title
The Fugl-Meyer Assessment (FMA)
Description
Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.
Time Frame
8 week
Secondary Outcome Measure Information:
Title
The Fugl-Meyer Assessment (FMA)
Description
Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.
Time Frame
16 week
Title
modified Barthel Index (mBI)
Description
to evaluate the daily life function, including stool, urine, dressing, using the toilet, eating, transfer, walking for 45 meters, wearing clothes, going up and down stairs, and bathing.
Time Frame
8 week, 16 week
Title
Stroke syndrome of traditional Chinese medicine (SSTCM)
Description
self-rating scale that reflects the quality of life of stroke patients
Time Frame
8 week, 16 week
Title
fractional amplitude of low frequency fluctuation (fALFF)
Description
fALFF aquired by fMRI technique measures the relative contribution of low frequency fluctuations within a specific frequency band to the whole detectable frequencyrange
Time Frame
8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet to criteria for diagnosis and efficacy evaluation of stroke, formulated by The State Administration of Traditional Chinese Medicine Encephalopathy Emergency Cooperative Group in 1996 (trial implementation)
Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China in 2014 (Neurology Branch of Chinese Medical Association and Cerebrovascular Disease Association of Neurology Branch of Chinese Medical Association, 2015)
Ischemic stroke diagnosed by CT or magnetic resonance imaging (MRI), with the presence of stable vital signs and awareness
An age of 40-70 years Onset within 1-6 months
Motor dysfunction in the extremities
A Mini-Mental State Examination (Pangman et al., 2000) score > 24 points
Exclusion Criteria:
Consciousness disorder or severe cognitive impairment
Severe Parkinson's disease, heart disease, cancer, epilepsy, or chronic alcoholism
Hepatic or renal impairment
Hemorrhagic tendency
Sensitivity to acupuncture
Congenital disability
Pregnancy
Currently participating in other clinical trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jian
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Longhua hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35673804
Citation
Zhan Y, Pei J, Wang J, Fu Q, Xu J, Yan M, Cai Y, Cui X, Ye W, Fan M, Yu Q, Jia J. Motor function and fALFF modulation in convalescent-period ischemic stroke patients after scalp acupuncture therapy: a multi-centre randomized controlled trial. Acupunct Med. 2023 Apr;41(2):86-95. doi: 10.1177/09645284221086289. Epub 2022 Jun 7.
Results Reference
derived
Learn more about this trial
Scalp Acupuncture for Dyskinesia After Ischemic Stroke
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