Evaluation of the Safety and Performance of the NESS L300 Plus System

Phase 3

Completed

• Conditions: Foot Drop; Thigh Muscles Weakness (Hamstrings or Quadriceps); Upper Motor Neuron Injury or Disease

• Registration Number: NCT01237860
• Lead Sponsor: Bioness Inc

Brief Summary

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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-14
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Occurence of anticipated and unanticipated adverse events	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.
Subject feedback regarding the safety of using the device	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.

Secondary Outcome Measures

Name	Time	Method
Temporal Gait Parameters of the 2 Minute Walk Test	Week 1 and Week 6	This outcome measure includes the following: gait velocity, gait asymmetry, single limb support (percentage of the singe stance phase).
10 Meter Obstacle Course Walking Velocity	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.

Trial Locations

Locations (1)

Reuth Medical Center; 🇮🇱 Tel-Aviv, Israel