search
Back to results

Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke

Primary Purpose

Stroke, Upper Extremity Paresis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring StartReact response, transcranial direct current stimulation, Postural control

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for stroke:

  • Unilateral cortical or white matter subcortical stroke
  • Age 40 yrs and older
  • ≥ 6 months post ischemic stroke or ≥ 12 months post hemorrhagic stroke
  • Residual arm hemiparesis as indicated by Fugl-Meyer Upper Extremity score between 20-65
  • Having the ability to perform reaching movements with the paretic arm in standing without an assistive device.

Exclusion Criteria for stroke:

  • Stroke involving bilateral hemisphere, brainstem or cerebellum
  • Any medical condition precluding participation in testing
  • Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke.

Inclusion Criteria for healthy controls:

  • Age-matched to the stroke subjects
  • Without a history of stroke or any known neurological conditions
  • Having the cognitive ability to follow two-step commands and give informed consent

Exclusion Criteria for healthy controls:

  • Any medical condition precluding participation in testing
  • Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke.

Participants were also excluded if they did not meet the TMS safety criterion including having implantable medical devices, history of seizures, taking medications to reduce anxiety, sedatives, and seizure, and pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    tDCS over PMAs

    tDCS over M1

    Arm Description

    One session of transcranial direct current stimulation (tDCS) over premotor areas (PMAs)

    One session of transcranial direct current stimulation (tDCS) over primary motor area (M1)

    Outcomes

    Primary Outcome Measures

    Change in startReact response
    The incidence of StartReact response following an loud acoustic stimulus
    Change in the lag between anticipatory postural adjustments and reach onset
    The temporal lag between anticipatory postural adjustments (APA) onset and reach onset (unit: seconds)

    Secondary Outcome Measures

    Change in the reach onset (unit: seconds)
    The onset of the anterior wrist joint center movement with a threshold of 5% peak velocity
    Change in the APA onset (unit: seconds)
    The onset of the posterior center of pressure displacement with a threshold of 5% peak velocity
    Change in the amount of trunk flexion (unit: radians)
    The angular displacement of the line joining the reaching shoulder and the hip joint center on the same side in the sagittal plane at maximum reach normalized by reach distance
    Change in the amount of trunk rotation (unit: radians)
    The angular displacement of the line connecting both shoulders in the horizontal plane in the direction of the reach at maximum reach normalized by reach distance
    Change in the amount of pelvic rotation (unit: radians)
    The angular displacement of the line connecting both hip joint centers in the horizontal plane in the direction of the reach at maximum reach normalized by reach distance
    Change in the amount of trunk-pelvic rotation difference (unit: radians)
    The difference between trunk and pelvic angular displacement at maximum reach normalized by reach distance

    Full Information

    First Posted
    March 3, 2020
    Last Updated
    March 11, 2020
    Sponsor
    University of Maryland, Baltimore
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04308629
    Brief Title
    Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke
    Official Title
    Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    October 30, 2017 (Actual)
    Study Completion Date
    October 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Maryland, Baltimore

    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
    Stroke is the leading cause of disability and diminished quality of living that frequently includes impairments of postural control and upper extremity (UE) function. The interaction of posture and UE coupling in terms of movement planning, initiation, and execution is not well understood. StartReact responses triggered by a loud acoustic stimulus (LAS) during the planning and preparation of goal intended actions has been used to probe the state of brainstem neuronal excitability related to posture and movement sequencing. The purpose of this study is to examine posture and goal-directed movement planning and execution using startReact responses and to evaluate posture and UE movement sequence during reaching while standing in individuals with chronic hemiparesis and healthy controls. Secondly, the investigators will determine the modulatory role of the cortical premotor areas (PMAs) in startReact responses in healthy controls and in persons with stroke by using transcranial direct current stimulation (tDCS) to up- or down-regulate PMAs excitability.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Upper Extremity Paresis
    Keywords
    StartReact response, transcranial direct current stimulation, Postural control

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    tDCS over PMAs
    Arm Type
    Experimental
    Arm Description
    One session of transcranial direct current stimulation (tDCS) over premotor areas (PMAs)
    Arm Title
    tDCS over M1
    Arm Type
    Active Comparator
    Arm Description
    One session of transcranial direct current stimulation (tDCS) over primary motor area (M1)
    Intervention Type
    Other
    Intervention Name(s)
    Transcranial direct current stimulation
    Primary Outcome Measure Information:
    Title
    Change in startReact response
    Description
    The incidence of StartReact response following an loud acoustic stimulus
    Time Frame
    Immediately after the intervention (one session tDCS)
    Title
    Change in the lag between anticipatory postural adjustments and reach onset
    Description
    The temporal lag between anticipatory postural adjustments (APA) onset and reach onset (unit: seconds)
    Time Frame
    Immediately after the intervention (one session tDCS)
    Secondary Outcome Measure Information:
    Title
    Change in the reach onset (unit: seconds)
    Description
    The onset of the anterior wrist joint center movement with a threshold of 5% peak velocity
    Time Frame
    Immediately after the intervention (one session tDCS)
    Title
    Change in the APA onset (unit: seconds)
    Description
    The onset of the posterior center of pressure displacement with a threshold of 5% peak velocity
    Time Frame
    Immediately after the intervention (one session tDCS)
    Title
    Change in the amount of trunk flexion (unit: radians)
    Description
    The angular displacement of the line joining the reaching shoulder and the hip joint center on the same side in the sagittal plane at maximum reach normalized by reach distance
    Time Frame
    Immediately after the intervention(one session tDCS)
    Title
    Change in the amount of trunk rotation (unit: radians)
    Description
    The angular displacement of the line connecting both shoulders in the horizontal plane in the direction of the reach at maximum reach normalized by reach distance
    Time Frame
    Immediately after the intervention (one session tDCS)
    Title
    Change in the amount of pelvic rotation (unit: radians)
    Description
    The angular displacement of the line connecting both hip joint centers in the horizontal plane in the direction of the reach at maximum reach normalized by reach distance
    Time Frame
    Immediately after the intervention (one session tDCS)
    Title
    Change in the amount of trunk-pelvic rotation difference (unit: radians)
    Description
    The difference between trunk and pelvic angular displacement at maximum reach normalized by reach distance
    Time Frame
    Immediately after the intervention (one session tDCS)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria for stroke: Unilateral cortical or white matter subcortical stroke Age 40 yrs and older ≥ 6 months post ischemic stroke or ≥ 12 months post hemorrhagic stroke Residual arm hemiparesis as indicated by Fugl-Meyer Upper Extremity score between 20-65 Having the ability to perform reaching movements with the paretic arm in standing without an assistive device. Exclusion Criteria for stroke: Stroke involving bilateral hemisphere, brainstem or cerebellum Any medical condition precluding participation in testing Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke. Inclusion Criteria for healthy controls: Age-matched to the stroke subjects Without a history of stroke or any known neurological conditions Having the cognitive ability to follow two-step commands and give informed consent Exclusion Criteria for healthy controls: Any medical condition precluding participation in testing Other health conditions affecting balance and upper extremity movement function beyond the effects of stroke. Participants were also excluded if they did not meet the TMS safety criterion including having implantable medical devices, history of seizures, taking medications to reduce anxiety, sedatives, and seizure, and pregnancy.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33413441
    Citation
    Yang CL, Gad A, Creath RA, Magder L, Rogers MW, Waller SM. Effects of transcranial direct current stimulation (tDCS) on posture, movement planning, and execution during standing voluntary reach following stroke. J Neuroeng Rehabil. 2021 Jan 7;18(1):5. doi: 10.1186/s12984-020-00799-8.
    Results Reference
    derived

    Learn more about this trial

    Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke

    We'll reach out to this number within 24 hrs