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Learning in Stroke

Primary Purpose

Stroke, Sensorimotor Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visuomotor learning task
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring procedural learning, maladaptive plasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

stroke group

control group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2022
Last Updated
September 15, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05511467
Brief Title
Learning in Stroke
Official Title
Neural Circuitries of Motor Learning as a Target to Modulate Sensorimotor Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Sensorimotor Impairment
Keywords
procedural learning, maladaptive plasticity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stroke group
Arm Type
Experimental
Arm Title
control group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Visuomotor learning task
Intervention Description
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'.
Primary Outcome Measure Information:
Title
Learning rate as indexed by change in the precision of visuomotor grip force adjustment
Description
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.
Time Frame
Pre Learning Session and Post Learning Session (approximately 90 minutes)
Title
2. Change in blood-oxygen-level-dependent (BOLD) signal derived multi-voxel brain activation
Description
Learning-related change of brain activation is defined based on changes in multi-voxel patterns of BOLD-signal-derived brain activation.
Time Frame
Pre Learning Session and Post Learning Session (approximately 90 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirstin-Friederike Heise, PhD
Phone
(843)792-3435
Email
heisek@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Krajeck, MHA
Phone
(843)792-9329
Email
krajeck@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirstin-Friederike Heise, PhD
Phone
843-792-3435
Email
heisek@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Learning in Stroke

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