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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
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 11, 2017
Last Updated
September 5, 2022
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Fudan University
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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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