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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465281
• Other study ID #: 1503M66381
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: September 23, 2016

Study information

• Verified date: March 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 23, 2016
• Est. primary completion date: September 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Device: 3T scanner with MRI-compatible robot

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structural and Functional Imaging	Identify correlations between brain lesions and sensimotor impairments in stroke	1 week
Primary	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