NCT02351947

Brief Summary

The purpose of this research study is to improve methods for evaluation of brain changes during motor learning for patients with stroke, who have difficulty performing daily tasks with their arm and hand. The methods for evaluation of brain changes will consist of the combination of magnetic resonance imaging (MRI) and electroencephalography (EEG).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

9.7 years

First QC Date

December 16, 2014

Last Update Submit

April 4, 2022

Conditions

Cerebrovascular Accident

Keywords

strokeCerebrovascular accidentrehabilitationmotor learningfMRIplasticity

Outcome Measures

Primary Outcomes (2)

  • functional MRI during movement of the shoulder and elbow

    MRI allows for observation of the internal structures of the body using a magnetic field and radiowaves. We will measure activation voxel count in response to training.

    up to 3 months

  • Electroencephalography (EEG) during movement of the shoulder and elbow

    EEG is used to record electrical signals released by the brain. We will assess changes in the movement related cortical potentional (MRCP, measured in microvolts) in response to training.

    Day 1 and following 3 months of intervention

Study Arms (2)

persons with chronic stroke

EXPERIMENTAL

upper limb rehabilitation for chronic stroke

Other: upper limb rehabilitation for chronic stroke

Healthy, age matched control group

NO INTERVENTION

Healthy aged match control group undergoing MRI/EEG testing

Interventions

upper limb rehabilitation for chronic strokeOTHER

subjects in this group will receive upper limb motor learning rehabilitation and undergo fMRI/EEG testing as well as testing of motor function (AMAT and FM).

persons with chronic stroke

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medically stable and at least 6 months post ischemic stroke.
  • Inability to use upper limb for functional tasks
  • Sufficient endurance to participate in rehabilitation
  • Cognition sufficiently intact to give valid informed consent to participate
  • Ability to follow two stage commands
  • Trace or better contraction of the following muscles: finger flexors, wrist flexors and extensors, shoulder flexors or abductors, shoulder horizontal abductors, scapular retractors
  • Muscle tone of fingers, wrist and elbow flexors ≤3 (Ashworth scale)
  • Age \> 21

You may not qualify if:

  • Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy
  • Active psychiatric diagnosis or psychological condition
  • Lower motor neuron damage or radiculopathy
  • Hand grasp and release sufficient to grasp 4 oz. can, lift 12 inches, replace it in original position and release grasp within 1-2 seconds of the time of the unaffected extremity
  • Absent position sense at elbow or wrist
  • More than one ischemic strokes or stroke affecting both sides
  • Metal implants, pacemaker, claustrophobia, or inability to operate the MRI patient call button

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Stokes Cleveland Department of Veterans Affairs Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Svetlana Pundik, M.D.

    Louis Stokes VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Brain Plasticity and Neurorecovery Laboratory

Study Record Dates

First Submitted

December 16, 2014

First Posted

January 30, 2015

Study Start

April 1, 2009

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 5, 2022

Record last verified: 2022-04

Locations

US(1)