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Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke

Primary Purpose

Chronic Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tDCS(Intelect Mobile Stimulation and Combination, DJO, France)
NMES(Enraf Nonius, Endomed-182, Netherlands)
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Transcranial direct current stimulation, Neuromuscular electrical stimulation, Stroke, Rehabilitation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First onset
  • Ischemic stroke
  • Stroke onset > 6 months
  • Brunnstrom recovery stage: ≧3
  • Modified Ashworth Scale Elbow flexor : ≦3

Exclusion Criteria:

  • Severe language or cognitive impairment
  • Orthopaedic or neurological problems
  • Pregnancy
  • Contraindications for tDCS or NMES

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Arm Label

    tDCS combined with NMES

    tDCS combined with sham NMES

    sham tDCS combined with sham NMES

    Arm Description

    In addition to conventional rehabilitation, all subjects received an additional tDCS combined with NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

    In addition to conventional rehabilitation, all subjects received an additional tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

    In addition to conventional rehabilitation, all subjects received an additional sham tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

    Outcomes

    Primary Outcome Measures

    upper extremity subscale of Fugl-Meyer assessment
    The Fugl-Meyer assessment consists of the 33-item upper-extremity (UE-FM) and 17-item lower-extremity subscales.(Fugl-Meyer et al., 1975) The items of the FM are mainly scored on a 3-point scale, from 0 to 2. The total score of the UE-FM ranges from 0 to 66.
    Action Research Arm Test
    The ARAT(Lyle, 1981) has 19 items in four categories: grasp, grip, pinch, and gross movement. Each item is graded on a 4-point scale, from 0 to 3. The total score has a range of 0 to 57.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 14, 2019
    Last Updated
    August 15, 2019
    Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04059848
    Brief Title
    Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 13, 2017 (Actual)
    Primary Completion Date
    July 30, 2019 (Actual)
    Study Completion Date
    July 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to investigate the effects of the combination treatment strategy. A randomized, double-blinded and sham-stimulation study was conducted. Twenty-six participants with chronic stroke (onset > 6 months) were assigned into one of three groups (tDCS combined with NMES, tDCS combined with sham NMES, or sham tDCS combined with sham NMES) by block randomization. In addition to conventional rehabilitation, all subjects received an additional protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). The UE subscale of Fugl-Meyer assessment (UE-FMA) and Action Research Arm Test (ARAT) as primary outcome measures were assessed at beginning of the intervention, after 3-week of treatment, and one-month follow-up. No significant differences in the primary outcome measures at post-treatment and one-month follow-up were found among the tDCS combined with NMES group (n=9), tDCS combined with sham NMES group (n=9), and the sham tDCS combined with sham NMES group (n=8). However, significant changes in UE-FMA (from baseline to post-treatment, p= .02) and ARAT (from baseline to post-treatment, p= .04) score were found for the tDCS combined with NMES group. This preliminary study reveals that the tDCS combined with NMES appears to be beneficial to UE motor recovery after stroke but is not superior to the tDCS alone.
    Detailed Description
    Background and objectives: Previous studies have shown that transcranial direct current stimulation (tDCS) and Neuromuscular electrical stimulation (NMES) could be effective for promoting motor recovery of stroke patients. However, the effects of tDCS combined with NMES on upper extremity (UE) motor recovery in patients with stroke have not been investigated. The purpose of this study was to investigate the effects of the combination treatment strategy. Methods: A randomized, double-blinded and sham-stimulation study was conducted. Twenty-six participants with chronic stroke (onset > 6 months) were assigned into one of three groups (tDCS combined with NMES, tDCS combined with sham NMES, or sham tDCS combined with sham NMES) by block randomization. In addition to conventional rehabilitation, all subjects received an additional protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). The UE subscale of Fugl-Meyer assessment (UE-FMA) and Action Research Arm Test (ARAT) as primary outcome measures were assessed at beginning of the intervention, after 3-week of treatment, and one-month follow-up. Results: Most of the participants had mild to moderate disability in activity of daily living. No significant differences in the primary outcome measures at post-treatment and one-month follow-up were found among the tDCS combined with NMES group (n=9), tDCS combined with sham NMES group (n=9), and the sham tDCS combined with sham NMES group (n=8). However, significant changes in UE-FMA (from baseline to post-treatment, p= .02) and ARAT (from baseline to post-treatment, p= .04) score were found for the tDCS combined with NMES group. Conclusion: This preliminary study reveals that the tDCS combined with NMES appears to be beneficial to UE motor recovery after stroke but is not superior to the tDCS alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Stroke
    Keywords
    Transcranial direct current stimulation, Neuromuscular electrical stimulation, Stroke, Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tDCS combined with NMES
    Arm Type
    Experimental
    Arm Description
    In addition to conventional rehabilitation, all subjects received an additional tDCS combined with NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).
    Arm Title
    tDCS combined with sham NMES
    Arm Type
    Active Comparator
    Arm Description
    In addition to conventional rehabilitation, all subjects received an additional tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).
    Arm Title
    sham tDCS combined with sham NMES
    Arm Type
    Sham Comparator
    Arm Description
    In addition to conventional rehabilitation, all subjects received an additional sham tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).
    Intervention Type
    Combination Product
    Intervention Name(s)
    tDCS(Intelect Mobile Stimulation and Combination, DJO, France)
    Intervention Type
    Combination Product
    Intervention Name(s)
    NMES(Enraf Nonius, Endomed-182, Netherlands)
    Primary Outcome Measure Information:
    Title
    upper extremity subscale of Fugl-Meyer assessment
    Description
    The Fugl-Meyer assessment consists of the 33-item upper-extremity (UE-FM) and 17-item lower-extremity subscales.(Fugl-Meyer et al., 1975) The items of the FM are mainly scored on a 3-point scale, from 0 to 2. The total score of the UE-FM ranges from 0 to 66.
    Time Frame
    at beginning of the intervention, after 3-week of treatment, and one-month follow-up
    Title
    Action Research Arm Test
    Description
    The ARAT(Lyle, 1981) has 19 items in four categories: grasp, grip, pinch, and gross movement. Each item is graded on a 4-point scale, from 0 to 3. The total score has a range of 0 to 57.
    Time Frame
    at beginning of the intervention, after 3-week of treatment, and one-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: First onset Ischemic stroke Stroke onset > 6 months Brunnstrom recovery stage: ≧3 Modified Ashworth Scale Elbow flexor : ≦3 Exclusion Criteria: Severe language or cognitive impairment Orthopaedic or neurological problems Pregnancy Contraindications for tDCS or NMES

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke

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