Cortical Enhancement of Posture, Movement Planning, and Execution of Upright Reaching Following Stroke
1 other identifier
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Oct 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2017
CompletedFirst Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 16, 2020
CompletedMarch 16, 2020
February 1, 2020
1.1 years
March 3, 2020
March 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in startReact response
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
The temporal lag between anticipatory postural adjustments (APA) onset and reach onset (unit: seconds)
Immediately after the intervention (one session tDCS)
Secondary Outcomes (6)
Change in the reach onset (unit: seconds)
Immediately after the intervention (one session tDCS)
Change in the APA onset (unit: seconds)
Immediately after the intervention (one session tDCS)
Change in the amount of trunk flexion (unit: radians)
Immediately after the intervention(one session tDCS)
Change in the amount of trunk rotation (unit: radians)
Immediately after the intervention (one session tDCS)
Change in the amount of pelvic rotation (unit: radians)
Immediately after the intervention (one session tDCS)
- +1 more secondary outcomes
Study Arms (2)
tDCS over PMAs
EXPERIMENTALOne session of transcranial direct current stimulation (tDCS) over premotor areas (PMAs)
tDCS over M1
ACTIVE COMPARATOROne session of transcranial direct current stimulation (tDCS) over primary motor area (M1)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33413441DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 16, 2020
Study Start
October 1, 2016
Primary Completion
October 30, 2017
Study Completion
October 30, 2017
Last Updated
March 16, 2020
Record last verified: 2020-02