Clinical trial NCT05511467: Learning in Stroke
Official title: Neural Circuitries of Motor Learning as a Target to Modulate Sensorimotor Recovery After Stroke
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Sensorimotor Impairment
Keywords: procedural learning
maladaptive plasticity
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2022-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke survivors (\>6 months) after their index lesion, ≥18 years of age. Healthy adults (≥18 years of age).

Brief summary: After a stroke, plasticity occurs in the brain from microscopic to network level with positive but also negative consequences for functional recovery. Why post-stroke plasticity takes a beneficial or a maladaptive direction is still incompletely understood. Because the biological mechanisms underlying sensorimotor learning parallel those observed during recovery, learning mechanisms could be potential modifiers of post-stroke neuroplasticity and have a discrete mal-/adaptive impact on the recovery of sensorimotor function. This project seeks to further the understanding of the link between brain circuits that control the integration of new information during procedural learning in the injured brain and those circuits that are involved in adaptive plastic changes during recovery of sensorimotor function post-stroke. The project's methodological approach will allow the characterization of procedural learning-related neural network dynamics based on functional magnetic resonance imaging (MRI) in human volunteers with and without neurologically impairment post-stroke. Through multivariate integration of behavioral and biological descriptors of sensorimotor recovery, the project will investigate the association between motor learning-related network dynamics and descriptors of recovery.


Eligibility criteria: INCLUSION CRITERIA

For all participants:

* adult volunteers (age ≥18 years)
* right-hand dominance as defined by the Edinburgh Handedness Inventory

Stroke-specific inclusion criteria:

* ischemic or hemorrhagic lesion
* subcortical or cortical tissue involvement
* chronic phase (\>6 months) after their index lesion
* voluntary whole-hand grip force (MRC, Medical Research Council scale for muscle force ≥2)
* repeated release (standardized as a reduction of 50% of maximum voluntary contraction measured with a dynamometer)

EXCLUSION CRITERIA

For all participants:

* Presence of any MRI risk factors
* substance use disorder
* psychotic disorders

Stroke-group specific exclusion criteria:

* Primary intracerebral hematoma
* subarachnoid hemorrhage
* bi-hemispheric or cerebellar strokes
* other concomitant neurological disorders affecting upper extremity motor function
* documented history of dementia before or after stroke
* severe aphasia, particularly of receptive nature (NIHSS Language subsection ≥2), affecting their ability to understand the purpose of the study and give informed consent
* uncontrolled hypertension despite treatment
* intake of tricyclic anti-depressants or neuroleptic medication.

Primary outcomes:
measure: Learning rate as indexed by change in the precision of visuomotor grip force adjustment
timeFrame: Pre Learning Session and Post Learning Session (approximately 90 minutes)
measure: 2. Change in blood-oxygen-level-dependent (BOLD) signal derived multi-voxel brain activation
timeFrame: Pre Learning Session and Post Learning Session (approximately 90 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: