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Completed

NCT Number: NCT02465281

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device: 3T scanner with MRI-compatible robot

Other

Primary outcomes

  1. Structural and Functional Imaging

    Time frame: 1 week

    Identify correlations between brain lesions and sensimotor impairments in stroke

  2. 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2015
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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