Learning in Stroke

Stroke Clinical Trial

Official title:

Neural Circuitries of Motor Learning as a Target to Modulate Sensorimotor Recovery After Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05511467
• Other study ID #: 00116626
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Visuomotor learning task
Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Learning rate as indexed by change in the precision of visuomotor grip force adjustment	1. Isometric whole-hand grip force is captured continuously with grip-force transducers (at 1000Hz) and adjusted relative to the individual maximum voluntary contraction.; Precision of force adjustment is based on the recorded muscle force monitored during task performance and defined as the actual force exerted by the participant relative to the target force (measurement unit: precision in %), with positive values indicating over- and negative values indicating undershoot. Learning rate from before to after learning will be defined as the difference in precision between before as compared to after one single learning session.	Pre Learning Session and Post Learning Session (approximately 90 minutes)
Primary	2. Change in blood-oxygen-level-dependent (BOLD) signal derived multi-voxel brain activation	Learning-related change of brain activation is defined based on changes in multi-voxel patterns of BOLD-signal-derived brain activation.	Pre Learning Session and Post Learning Session (approximately 90 minutes)