- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04308629
Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke
March 11, 2020 updated by: Sandy McCombe Waller, University of Maryland, Baltimore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tDCS over PMAs
One session of transcranial direct current stimulation (tDCS) over premotor areas (PMAs)
|
|
Active Comparator: tDCS over M1
One session of transcranial direct current stimulation (tDCS) over primary motor area (M1)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in startReact response
Time Frame: Immediately after the intervention (one session tDCS)
|
The incidence of StartReact response following an loud acoustic stimulus
|
Immediately after the intervention (one session tDCS)
|
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)
|
Immediately after the intervention (one session tDCS)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Immediately after the intervention (one session tDCS)
|
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
|
Immediately after the intervention (one session tDCS)
|
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
|
Immediately after the intervention(one session tDCS)
|
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
|
Immediately after the intervention (one session tDCS)
|
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
|
Immediately after the intervention (one session tDCS)
|
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
|
Immediately after the intervention (one session tDCS)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
October 30, 2017
Study Completion (Actual)
October 30, 2017
Study Registration Dates
First Submitted
March 3, 2020
First Submitted That Met QC Criteria
March 11, 2020
First Posted (Actual)
March 16, 2020
Study Record Updates
Last Update Posted (Actual)
March 16, 2020
Last Update Submitted That Met QC Criteria
March 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00064894
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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