Clinical trial NCT04308629: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Keywords: StartReact response
transcranial direct current stimulation
Postural control
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in startReact response
timeFrame: Immediately after the intervention (one session tDCS)
measure: Change in the lag between anticipatory postural adjustments and reach onset
timeFrame: Immediately after the intervention (one session tDCS)
Secondary outcomes:
measure: Change in the reach onset (unit: seconds)
timeFrame: Immediately after the intervention (one session tDCS)
measure: Change in the APA onset (unit: seconds)
timeFrame: Immediately after the intervention (one session tDCS)
measure: Change in the amount of trunk flexion (unit: radians)
timeFrame: Immediately after the intervention(one session tDCS)
measure: Change in the amount of trunk rotation (unit: radians)
timeFrame: Immediately after the intervention (one session tDCS)
measure: Change in the amount of pelvic rotation (unit: radians)
timeFrame: Immediately after the intervention (one session tDCS)
measure: Change in the amount of trunk-pelvic rotation difference (unit: radians)
timeFrame: Immediately after the intervention (one session tDCS)
Other outcomes:
Locations:
Study officials:
References:
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.