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Correlation Analysis Between Brain Lesions and Sensorimotor Impairments in Individuals With Stroke (Preliminary Study)

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ClinicalTrials.gov Identifier: NCT02465281
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:

The objective of the preliminary study is:

  1. To identify correlations between brain lesions and sensorimotor impairments in stroke.
  2. To identify possible patterns between brain lesions and sensorimotor impairments that might increase our understanding in stroke recovery and guide further tailor-based neuro-rehabilitation

Condition or disease Intervention/treatment
Stroke Other: Device: 3T scanner with MRI-compatible robot

Detailed Description:
The purpose of this study is to investigate arm and hand function after stroke and how the location of the brain lesion affects arm and hand function. We are hoping to collect data in the form of assessments what you feel and how your arm moves, surveys about activities in daily life and well-being, and we will perform 1 Magnetic Resonance Imaging (MRI) scan. MRI scans are loud but painless; nothing is injected. With MRI, we collect images from the brain.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation Analysis Between Brain Lesions and Sensorimotor Impairments in Individuals With Stroke (Preliminary Study)
Study Start Date : October 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Group/Cohort Intervention/treatment
Stroke patients
20 patients who are at least 6 months post stroke. Device: 3T scanner with MRI-compatible robot
Other: Device: 3T scanner with MRI-compatible robot
Healthy volunteers
80 age-matched healthy volunteers
Other: Device: 3T scanner with MRI-compatible robot



Primary Outcome Measures :
  1. Structural and Functional Imaging [ Time Frame: 1 week ]
    Identify correlations between brain lesions and sensimotor impairments in stroke

  2. Identify Possible Patterns [ Time Frame: 1 week ]
    Identify possible patterns between brain lesions and senosrimotor impairments that might increase our understanding in stroke recovery and guide further tailor-based neuro-rehabilitation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Control Group Stroke patient subjects
Criteria

Inclusion Criteria:

  • Inclusion criteria for healthy subjects are:

    • medically stable;
    • 18 - 99 years of age;
    • able to hear the instructions given during the study

Inclusion criteria for stroke patients are:

  • at least 6 months post-stroke;
  • medically stable;
  • 18 - 99 years of age;
  • subcortical or cortical infarct confirmed with MRI;
  • Mini-mental State Exam > 24/30 (Folstein et al., 1975);
  • able to hear the instructions given during the study;
  • able to comprehend the instructions given during the study;
  • able to commit time to participate in a 6-12-weeks rehabilitation program

Exclusion Criteria:

Exclusion criteria for healthy subjects are:

  • having ever experienced a stroke or another brain injury or illness related to the brain that has lasting effects or effects experienced at the moment of recruitment;
  • severe sensory impairments such that different movements of the finger, hand or wrist are not reliably felt;
  • contractures in tested arm that hinder persons from keeping the outstretched arm in a relaxed position;
  • interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy);
  • exhibit contra-indications to enter the magnetic field of the 3T (pacemakers, metal parts in the body etc);
  • pregnant or nursing mother;
  • adults lacking capacity to consent

Exclusion criteria for stroke patients are:

  • insular or cerebellar infarcts/brain lesions;
  • unilateral spatial neglect, identified by a standard neuropsychological assessment (Bell's test (score/35, Gauthier et al., 1989);
  • aphasia;
  • apraxia (TULIA, Vanbellingen et al., 2011);
  • severe sensory impairments such that different movements of the finger, hand or wrist are not reliably felt;
  • contractures in the hemiplegic arm that hinder patients from keeping the outstretched arm in a relaxed position;
  • interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy);
  • patients currently receiving therapy for their hemiplegic arm, the latter in order to avoid confounding treatment effects;
  • exhibit contra-indications to enter the magnetic field of the 3T (pacemakers, metal parts in the body etc);
  • pregnant or nursing mother;
  • adults lacking capacity to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465281


Contacts
Contact: Ann Van de Winckel, PhD, MS, PT 612-625-1191 avandewi@umn.edu

Locations
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Anne Van de Winckel, PhD, MS, PT University of Minnesota - Clinical and Translational Science Institute

Additional Information:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02465281     History of Changes
Other Study ID Numbers: 1503M66381
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases