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Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis

Primary Purpose

Stroke, Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuroconn Eldith stimulator by Magstim
Sponsored by
Lumy Sawaki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring motor recovery, neuroplasticity, chronic, human, noninvasive brain stimulation, neuromodulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic stroke patients
  • Single stroke
  • Chronic (more than 12 months after from stroke)
  • At least 18 years old, but there is no upper age range for this project.
  • Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

Exclusion Criteria:

  • History of head injury with loss of consciousness, seizure, severe alcohol or drug abuse, psychiatric illness
  • Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
  • Cognitive deficit severe enough to preclude informed consent
  • Positive pregnancy test or being of childbearing age and not using appropriate contraception
  • Participants with history of untreated depression.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    Anodal tDCS with motor training

    Cathodal tDCS with motor training

    Dual tDCS with motor training

    Sham tDCS with motor training

    Arm Description

    20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.

    20 minutes of cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.

    20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere and cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.

    20 minutes of sham transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.

    Outcomes

    Primary Outcome Measures

    Change in Fugl Meyer Assessment

    Secondary Outcome Measures

    Change in Action Research Arm Test
    Change in Stroke Impact Scale

    Full Information

    First Posted
    April 18, 2017
    Last Updated
    April 21, 2017
    Sponsor
    Lumy Sawaki
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03124147
    Brief Title
    Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis
    Official Title
    Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (Actual)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lumy Sawaki

    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
    This study will compare the effectiveness of different polarities of transcranial direct current stimulation paired with intensive motor training in recovery of upper extremity function in individuals with severe post-stroke hemiparesis. The hypothesis is that more severely impaired individuals will derive greater benefit from anodal stimulation of the ipsilesional hemisphere or cathodal stimulation of the contralesional hemisphere than dual stimulation (anodal applied to the ipsilesional hemisphere and cathodal applied to the contralesional hemisphere.)
    Detailed Description
    This study has 2 aims: 1) determine which transcranial direct current stimulation (tDCS) electrode configuration is most effective in combination with motor training to promote motor recovery from severe post-stroke hemiparesis; and 2) begin to clarify the extent to which baseline transcranial magnetic stimulation (TMS) measures predict response to tDCS, as well as the effects of tDCS paired with motor training on TMS measures of motor cortical organization. To accomplish these aims, the investigators will recruit 36 human subjects with severe post-stroke hemiparesis and assign each subject to 1 of 4 tDCS conditions (anodal excitatory ipsilesional; cathodal inhibitory contralesional; a combination of anodal excitatory ipsilesional during cathodal inhibitory contralesional; or sham). Each subject will undergo a 20-minute stimulation session once a day for 10 days over a 2-week period. Each session will be followed by 3 hours of intensive, task-oriented upper extremity motor training. Outcome measures for this study include TMS motor cortical maps and standardized tests of motor performance. The investigators hypothesize that all groups will show improvement in all measures; however, both the anodal excitatory ipsilesional group and the cathodal inhibitory contralesional group will show significantly greater improvement compared with the other 2 groups. The investigators will also find evidence clarifying whether the presence or absence of motor-evoked potentials (MEPs) has predictive value regarding which tDCS configuration would be most effective for a particular subject.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Cerebrovascular Accident
    Keywords
    motor recovery, neuroplasticity, chronic, human, noninvasive brain stimulation, neuromodulation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Anodal tDCS with motor training
    Arm Type
    Active Comparator
    Arm Description
    20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
    Arm Title
    Cathodal tDCS with motor training
    Arm Type
    Active Comparator
    Arm Description
    20 minutes of cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
    Arm Title
    Dual tDCS with motor training
    Arm Type
    Active Comparator
    Arm Description
    20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere and cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
    Arm Title
    Sham tDCS with motor training
    Arm Type
    Sham Comparator
    Arm Description
    20 minutes of sham transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
    Intervention Type
    Device
    Intervention Name(s)
    Neuroconn Eldith stimulator by Magstim
    Intervention Description
    Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
    Primary Outcome Measure Information:
    Title
    Change in Fugl Meyer Assessment
    Time Frame
    Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
    Secondary Outcome Measure Information:
    Title
    Change in Action Research Arm Test
    Time Frame
    Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
    Title
    Change in Stroke Impact Scale
    Time Frame
    Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic stroke patients Single stroke Chronic (more than 12 months after from stroke) At least 18 years old, but there is no upper age range for this project. Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°. Exclusion Criteria: History of head injury with loss of consciousness, seizure, severe alcohol or drug abuse, psychiatric illness Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery Cognitive deficit severe enough to preclude informed consent Positive pregnancy test or being of childbearing age and not using appropriate contraception Participants with history of untreated depression.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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