StrokeNCT02076581
MyoSense- Automated Muscle Hypertonicity Classification System
An observational study of Stroke and Dystonia, run by Great Lakes NeuroTechnologies Inc. at 1 site in United States.
Trial summary
It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to neurological injury. This makes it difficult to evaluate therapies that aim to reduce the effects of abnormal muscle tone. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Dystonia, Cerebral Palsy
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2015
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Sixty individuals, including individuals with and without abnormal muscle tone will be recruited for this study.
Who may be able to join
- Presentation of dystonia and/or spasticity or, if in control group, no neurological injury nor abnormal muscle tone
- Over the age of five.
Who cannot join
- Intolerable pain with manipulation of the knee, ankle, wrist, or elbow
- Limited range of motion in the knee, ankle, wrist or elbow due to orthopedic injury or severe contraction.
- Cognitive impairment resulting in inability to provide informed consent or complete the protocol.
- Under the age of five.
Trial locations and contacts
1 site in 1 country.
United States1 site
Great Lakes NeuroTechnologies
Valley View, Ohio, 44125
About this study
It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to neurological injury. This makes it difficult to evaluate therapies that aim to reduce the effects of abnormal muscle tone. This research study will evaluate the feasibility of a clinician worn device to capture and quantify features of spasticity and dystonia.
- Conditions
- Stroke, Dystonia, Cerebral Palsy
- Medical subject headings
- Stroke, Dystonia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Ten individuals with chronic stroke and limb spasticity will be recruited. | |
| Dystonia | Ten individuals with dystonic limbs and no spasticity will be recruited. | |
| Cerebral Palsy | Ten individuals with Cerebral palsy with the potential for a mix of dystonic and spastic abnormal tone in their affected limbs will be recruited. | |
| Neurologically normal | Thirty individuals without neurological injury that are age matched to the rest of the study population will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between clinician and device measured abnormal tone type.
Device measurements of clinician applied force relative to limb manipulation speed will be compared to conventional clinical outcome measures. For example, correlation between the slope of the force to speed profile and clinician evaluated spasticity, Ashworth score, will be calculated.
Measured: For each subject clinician and device data will be collected within a single session. Each session will occur over a maximum of two hours. Analysis of all of the subject data will be completed within 30 days of study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionApr 2015
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
- Cross-sectional
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Joseph P Giuffrida, PhD, Principal investigator, Great Lakes NeuroTechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076581
- Sponsor's protocol ID
- NS076052-1
- Other IDs
- 1R43NS076052-01A1
- Status last verified
- May 2015
- First submitted
- 20 Feb 2014
- Last updated
- 1 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyoSense- Automated Muscle Hypertonicity Classification System
- ClinicalTrials.gov ID
- NCT02076581
- Acronym / sponsor ID
- NS076052-1
- Conditions
- Stroke, Dystonia, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Mar 2014 (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.
It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to neurological injury. This makes it difficult to evaluate therapies that aim to reduce the effects of abnormal muscle tone. This research study will evaluate the feasibility of a clinician worn device to capture and quantify features of spasticity and dystonia.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | –Ten individuals with chronic stroke and limb spasticity will be recruited. |
| Dystonia | – | –Ten individuals with dystonic limbs and no spasticity will be recruited. |
| Cerebral Palsy | – | –Ten individuals with Cerebral palsy with the potential for a mix of dystonic and spastic abnormal tone in their affected limbs will be recruited. |
| Neurologically normal | – | –Thirty individuals without neurological injury that are age matched to the rest of the study population will be recruited. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sixty individuals, including individuals with and without abnormal muscle tone will be recruited for this study.
Key inclusion criteria (2 listed)
- Presentation of dystonia and/or spasticity or, if in control group, no neurological injury nor abnormal muscle tone
- Over the age of five.
Key exclusion criteria (4 listed)
- Intolerable pain with manipulation of the knee, ankle, wrist, or elbow
- Limited range of motion in the knee, ankle, wrist or elbow due to orthopedic injury or severe contraction.
- Cognitive impairment resulting in inability to provide informed consent or complete the protocol.
- Under the age of five.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between clinician and device measured abnormal tone type.
Time frame: For each subject clinician and device data will be collected within a single session. Each session will occur over a maximum of two hours. Analysis of all of the subject data will be completed within 30 days of study completion.
Device measurements of clinician applied force relative to limb manipulation speed will be compared to conventional clinical outcome measures. For example, correlation between the slope of the force to speed profile and clinician evaluated spasticity, Ashworth score, will be calculated.
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 1 Jun 2015.
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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.
Joseph P Giuffrida, PhD principal investigator
Great Lakes NeuroTechnologies Inc.
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 and Dystonia, run by Great Lakes NeuroTechnologies Inc. 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 2 inclusion and 4 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 1 Jun 2015. 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?
Correlation between clinician and device measured abnormal tone type. (time frame: For each subject clinician and device data will be collected within a single session. Each session will occur over a maximum of two hours. Analysis of all of the subject data will be completed within 30 days of study completion.). 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 1 Jun 2015.