MyoSense- Automated Muscle Hypertonicity Classification System

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 Overview

• Status: Completed
• Conditions: Stroke; Cerebral Palsy; Dystonia

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Valley View, Ohio, United States, 44125
      • Great Lakes NeuroTechnologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Sixty individuals, including individuals with and without abnormal muscle tone will be recruited for this study.

Description

Inclusion Criteria:

• Presentation of dystonia and/or spasticity or, if in control group, no neurological injury nor abnormal muscle tone
• Over the age of five.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Great Lakes NeuroTechnologies Inc.
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); The Cleveland Clinic
• Investigators: Principal Investigator: Joseph P Giuffrida, PhD, Great Lakes NeuroTechnologies Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): June 1, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Neuromuscular Manifestations; Dyskinesias; Cerebral Palsy; Muscle Hypertonia; Dystonia
• Other Study ID Numbers: NS076052-1; 1R43NS076052-01A1 (U.S. NIH Grant/Contract)