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

NCT02465281 | Completed

• 1 other identifier: 1503M66381
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the preliminary study is:

1. 1.To identify correlations between brain lesions and sensorimotor impairments in stroke.
2. 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

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Structural and Functional Imaging

  Identify correlations between brain lesions and sensimotor impairments in stroke

  1 week

• Identify Possible Patterns

  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

Study Arms (2)

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

Interventions

Device: 3T scanner with MRI-compatible robot OTHER

Healthy volunteers; Stroke patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Control Group Stroke patient subjects

You may qualify if:

• medically stable;
• years of age;
• able to hear the instructions given during the study
• at least 6 months post-stroke;
• medically stable;
• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anne Van de Winckel, PhD, MS, PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 8, 2015
• Study Start: October 1, 2015
• Primary Completion: September 23, 2016
• Study Completion: September 23, 2016
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

US (1)