Clinical trial NCT02465281: Correlation Analysis Between Brain Lesions and Sensorimotor Impairments in Individuals With Stroke (Preliminary Study)
Official title: Correlation Analysis Between Brain Lesions and Sensorimotor Impairments in Individuals With Stroke (Preliminary Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Control Group Stroke patient subjects

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.

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

Primary outcomes:
measure: Structural and Functional Imaging
timeFrame: 1 week
measure: Identify Possible Patterns
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Anne Van de Winckel, PhD, MS, PT
role: PRINCIPAL_INVESTIGATOR
References: