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
About this trial
This is an interventional treatment trial for Stroke focused on measuring StartReact response, transcranial direct current stimulation, Postural control
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.
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
NCT ID
NCT04308629
First Posted
March 3, 2020
Last Updated
March 11, 2020
Sponsor
University of Maryland, Baltimore
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
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