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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04308629
Recruitment Status : Completed
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Sandy McCombe Waller, University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Stroke Upper Extremity Paresis Other: Transcranial direct current stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tDCS over PMAs
One session of transcranial direct current stimulation (tDCS) over premotor areas (PMAs)
Other: Transcranial direct current stimulation
Active Comparator: tDCS over M1
One session of transcranial direct current stimulation (tDCS) over primary motor area (M1)
Other: Transcranial direct current stimulation



Primary Outcome Measures :
  1. Change in startReact response [ Time Frame: Immediately after the intervention (one session tDCS) ]
    The incidence of StartReact response following an loud acoustic stimulus

  2. Change in the lag between anticipatory postural adjustments and reach onset [ Time Frame: Immediately after the intervention (one session tDCS) ]
    The temporal lag between anticipatory postural adjustments (APA) onset and reach onset (unit: seconds)


Secondary Outcome Measures :
  1. Change in the reach onset (unit: seconds) [ Time Frame: Immediately after the intervention (one session tDCS) ]
    The onset of the anterior wrist joint center movement with a threshold of 5% peak velocity

  2. Change in the APA onset (unit: seconds) [ Time Frame: Immediately after the intervention (one session tDCS) ]
    The onset of the posterior center of pressure displacement with a threshold of 5% peak velocity

  3. Change in the amount of trunk flexion (unit: radians) [ Time Frame: Immediately after the intervention(one session tDCS) ]
    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

  4. Change in the amount of trunk rotation (unit: radians) [ Time Frame: Immediately after the intervention (one session tDCS) ]
    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

  5. Change in the amount of pelvic rotation (unit: radians) [ Time Frame: Immediately after the intervention (one session tDCS) ]
    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

  6. Change in the amount of trunk-pelvic rotation difference (unit: radians) [ Time Frame: Immediately after the intervention (one session tDCS) ]
    The difference between trunk and pelvic angular displacement at maximum reach normalized by reach distance



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sandy McCombe Waller, Principle Investigator, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT04308629    
Other Study ID Numbers: HP-00064894
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandy McCombe Waller, University of Maryland, Baltimore:
StartReact response
transcranial direct current stimulation
Postural control
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations