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

March 9, 2020 updated by: University of Minnesota

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Control Group Stroke patient subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structural and Functional Imaging
Time Frame: 1 week
Identify correlations between brain lesions and sensimotor impairments in stroke
1 week
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anne Van de Winckel, PhD, MS, PT, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

September 23, 2016

Study Completion (Actual)

September 23, 2016

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Device: 3T scanner with MRI-compatible robot

Subscribe