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

NCT ID: NCT02465281

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2016-09-23

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

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.

Conditions

Stroke

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Stroke patients

20 patients who are at least 6 months post stroke. Device: 3T scanner with MRI-compatible robot

Device: 3T scanner with MRI-compatible robot

Intervention Type: OTHER

Healthy volunteers

80 age-matched healthy volunteers

Device: 3T scanner with MRI-compatible robot

Intervention Type: OTHER

Interventions

Device: 3T scanner with MRI-compatible robot

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Van de Winckel, PhD, MS, PT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1503M66381

Identifier Type: -

Identifier Source: org_study_id