Scalp Acupuncture for Dyskinesia After Ischemic Stroke

Ischemic Stroke Clinical Trial

— LUSA  

Official title:

Scalp Acupuncture for Dyskinesia After Ischemic Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03120650
• Other study ID #: LUS64385700
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2017
• Est. completion date: March 20, 2023

Study information

• Verified date: September 2022
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: March 20, 2023
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Dyskinesias
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Scalp acupuncture
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.
• Conventional rehabilitation
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.

Locations

Country	Name	City	State
China	Longhua hospital	Shanghai
China	Longhua Hospital, Shanghai University of Traditional Chinese Medicine	ShangHai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Stroke syndrome of traditional Chinese medicine (SSTCM)	self-rating scale that reflects the quality of life of stroke patients	8 week, 16 week
Secondary	fractional amplitude of low frequency fluctuation (fALFF)	fALFF aquired by fMRI technique measures the relative contribution of low frequency ?uctuations within a speci?c frequency band to the whole detectable frequencyrange	8 week