StrokeNCT02465281
Correlation Analysis Between Brain Lesions and Sensorimotor Impairments in Individuals With Stroke (Preliminary Study)
An observational study of Stroke, run by University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Device: 3T scanner with MRI-compatible robot
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 23 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Control Group Stroke patient subjects
Who may be able to join
- medically stable;
- 18 - 99 years of age;
- able to hear the instructions given during the study
- at least 6 months post-stroke;
- medically stable;
- 18 - 99 years of age;
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- 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
Who cannot join
- 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;
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- 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;
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
The objective of the preliminary study is:
- To identify correlations between brain lesions and sensorimotor impairments in stroke.
- 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.
- Conditions
- Stroke
- Being tested
- Device: 3T scanner with MRI-compatible robot
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: 3T scanner with MRI-compatible robotOther
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | 20 patients who are at least 6 months post stroke. Device: 3T scanner with MRI-compatible robot Receives: Other: Device: 3T scanner with MRI-compatible robot | |
| Healthy volunteers | 80 age-matched healthy volunteers Receives: Other: Device: 3T scanner with MRI-compatible robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural and Functional Imaging
Identify correlations between brain lesions and sensimotor impairments in stroke
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start1 Oct 2015
- Primary completion23 Sep 2016
- Study completion23 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Van de Winckel, PhD, MS, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465281
- Sponsor's protocol ID
- 1503M66381
- Status last verified
- Mar 2020
- First submitted
- 29 May 2015
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis Between Brain Lesions and Sensorimotor Impairments in Individuals With Stroke (Preliminary Study)
- ClinicalTrials.gov ID
- NCT02465281
- Acronym / sponsor ID
- 1503M66381
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 23 Sep 2016 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the preliminary study is:
- To identify correlations between brain lesions and sensorimotor impairments in stroke.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: Device: 3T scanner with MRI-compatible robot20 patients who are at least 6 months post stroke. Device: 3T scanner with MRI-compatible robot |
| Healthy volunteers | – | Other: Device: 3T scanner with MRI-compatible robot80 age-matched healthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Control Group Stroke patient subjects
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: 3T scanner with MRI-compatible robot | Other | Healthy volunteers, Stroke patients |
Primary outcome
Structural and Functional Imaging
Time frame: 1 week
Identify correlations between brain lesions and sensimotor impairments in stroke
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Van de Winckel, PhD, MS, PT principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural and Functional Imaging (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.