Evaluation of the Safety and Performance of the NESS L300 Plus System (L300Plus)

November 14, 2011 updated by: Bioness Inc
The study is designed to evaluate the safety and efficacy of using the L300 Plus as a neuroprosthesis device for walking in patients following an UMN injury or disease. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, one-center, single group, repeated measures, non inferiority study. Forty-five (45) subjects suffering from foot drop and thigh muscles weakness due to upper motor neuron injury or disease will be evaluated for this study. Each subject will be in the study for six weeks. Clinical benefits will be measured through an assessment of the gait performance. In particular it will test the hypothesis that the NESS L300 Plus System which involves foot drop correction with thigh muscles activation, may achieve walking enhancements not inferior to those gained from using a system that only corrects foot drop (i.e. NESS L300).

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Reuth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Upper motor neuron lesion
  • Thigh muscle weakness - hamstrings or quadriceps strength of less than 4/5 according to manual muscle testing
  • Foot drop - toe drag during walking
  • Lower limb spasticity - 0-4 according to the modified Ashworth scale
  • Responsible mental state, able to follow multiple step directions
  • Between 18 and 80 years old
  • Available for participation in the study
  • Able to understand and sign the informed consent form
  • Able to walk independently or with an assistance device (e.g. cane, walker etc.) / spot guarding for at least 10 meters
  • Sufficient response to electrical stimulation (visible muscle contractions in a seated or prone position of each designated muscle separately)

Exclusion Criteria:

  • Subjects with a demand-type cardiac pacemaker, defibrillator or any electrical or metallic implant
  • Cancerous lesion of lower limb, present or suspected
  • Medical condition that prevents participation or would likely lead to inability to comply with the protocol [e.g.: congestive heart failure, patient receiving chemotherapy, uncontrolled epilepsy, etc]
  • Severe cognitive impairment (MMSE<21)
  • Severe neglect (Star cancellation test<30)
  • Skin lesion at the site of the stimulation electrodes
  • Change in bone-joint structures of the lower limb, such as contractures or deformations; fracture or dislocation, which would be adversely affected by motion from the stimulation
  • Pregnancy
  • Diagnosis of major depression or psychotic disorder
  • Participation in another investigation that may directly or indirectly affect the study results
  • Unable to tolerate electrical stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of anticipated and unanticipated adverse events
Time Frame: Throughout the 6 weeks of the study
The occurence of anticipated and unanticipated events will be documented at each scheduled evaluation. In addition, subjects will be instructed to report adverse events 24 hours per day during the study period.
Throughout the 6 weeks of the study
Subject feedback regarding the safety of using the device
Time Frame: Week 6
Patient feedback regarding the safety of using the device as reported during the study sessions and the completion of a satisfaction questionnaire will also be used to assess the system's safety.
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporal Gait Parameters of the 2 Minute Walk Test
Time Frame: Week 1 and Week 6
This outcome measure includes the following: gait velocity, gait asymmetry, single limb support (percentage of the singe stance phase).
Week 1 and Week 6
10 Meter Obstacle Course Walking Velocity
Time Frame: Week 1 and Week 6
To imitate daily life situations, average gait speed will be also determine by measuring the time to walk 10m over an obstacle course, using the protocol in the Emory Functional Ambulation Profile.
Week 1 and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioness Inc

Collaborators

Bioness Neuromodulation

Investigators

  • Principal Investigator: Jean-Jacques Vatine, MD, Reuth Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 14, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 Rev 04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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