Trial record 13 of 203 for:    Hypertonia

MyoSense- Automated Muscle Hypertonicity Classification System

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Great Lakes NeuroTechnologies Inc.
Sponsor:
Collaborators:
The Cleveland Clinic
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier:
NCT02076581
First received: February 20, 2014
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition
Stroke
Dystonia
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: MyoSense- Automated Muscle Hypertonicity Classification System

Resource links provided by NLM:


Further study details as provided by Great Lakes NeuroTechnologies Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02076581

Contacts
Contact: Elizabeth B Brokaw, PhD 2164462453 ebrokaw@glneurotech.com

Locations
United States, Ohio
Great Lakes NeuroTechnologies Recruiting
Valley View, Ohio, United States, 44125
Principal Investigator: Joseph Giuffrida, PhD         
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
The Cleveland Clinic
Investigators
Principal Investigator: Joseph P Giuffrida, PhD Great Lakes NeuroTechnologies Inc.
  More Information

No publications provided

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT02076581     History of Changes
Other Study ID Numbers: NS076052-1, 1R43NS076052-01A1
Study First Received: February 20, 2014
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Muscle Hypertonia
Cerebral Palsy
Dystonia
Dystonic Disorders
Stroke
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Movement Disorders
Neuromuscular Manifestations
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014