Scalp Acupuncture for Dyskinesia After Ischemic Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Scalp Acupuncture for Dyskinesia After Ischemic Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Other: Scalp acupuncture
* Other: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scalp acupuncture<br>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. | Other: Scalp acupuncture<br>* 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.<br>|
| Active Comparator: Conventional rehabilitation<br>number:58 Rehabilitation will be conducted for 1 hour five times per week (Monday through Friday) for 8 weeks. | Other: Conventional rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fugl-Meyer Assessment (FMA) | Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke. | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fugl-Meyer Assessment (FMA) | Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke. | 16 week | 
| 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. | 8 week, 16 week | 
| Stroke syndrome of traditional Chinese medicine (SSTCM) | self-rating scale that reflects the quality of life of stroke patients | 8 week, 16 week | 
| 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 | 8 week |