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CompletedNCT02465281Updated Mar 11, 2020

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

An observational study in Stroke, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-11.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
16
Ages
18 Years to 80 Years
Sex
All
01

Study 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
Read the 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.

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Conditions studied

  • Stroke

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03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 16 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy Control Group Stroke patient subjects

Eligibility criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherDevice: 3T scanner with MRI-compatible robot
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What researchers measure

Primary outcomes

  1. Structural and Functional Imaging

    Identify correlations between brain lesions and sensimotor impairments in stroke

    Time frame: 1 week

  2. 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

    Time frame: 1 week

07

Study locations

1 site
  • University of Minnesota Medical Center
    Minneapolis, Minnesota 55455, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02465281
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jun 8, 2015
Start date
Oct 1, 2015
Primary completion
Sep 23, 2016
Completion
Sep 23, 2016
Last update
Mar 11, 2020

Study contacts

Anne Van de Winckel, PhD, MS, PT
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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