- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02465281
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:
- To identify correlations between brain lesions and sensorimotor impairments in stroke.
- 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
Intervention / Treatment
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
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center
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-
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
|
|
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Healthy volunteers
80 age-matched healthy volunteers
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1503M66381
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.
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