Learning in Stroke

Sponsor
Medical University of South Carolina (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05511467
Collaborator
National Institutes of Health (NIH) (NIH)
48
1
2
19
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Visuomotor learning task
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Neural Circuitries of Motor Learning as a Target to Modulate Sensorimotor Recovery After Stroke
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: stroke group

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'.

Experimental: control group

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'.

Outcome Measures

Primary Outcome Measures

  1. Learning rate as indexed by change in the precision of visuomotor grip force adjustment [Pre Learning Session and Post Learning Session (approximately 90 minutes)]

    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.

  2. 2. Change in blood-oxygen-level-dependent (BOLD) signal derived multi-voxel brain activation [Pre Learning Session and Post Learning Session (approximately 90 minutes)]

    Learning-related change of brain activation is defined based on changes in multi-voxel patterns of BOLD-signal-derived brain activation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina
  • National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kirstin-Friederike Heise, PhD, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT05511467
Other Study ID Numbers:
  • 00116626
First Posted:
Aug 23, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kirstin-Friederike Heise, PhD, Assistant Professor, Medical University of South Carolina
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022