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

This study has been completed.
Sponsor:
Collaborator:
Bioness Neuromodulation
Information provided by (Responsible Party):
Bioness Inc
ClinicalTrials.gov Identifier:
NCT01237860
First received: November 8, 2010
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Foot Drop
Thigh Muscles Weakness (Hamstrings or Quadriceps)
Upper Motor Neuron Injury or Disease
Device: NESS L300 Plus System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Performance of the NESS L300 Plus System

Resource links provided by NLM:


Further study details as provided by Bioness Inc:

Primary Outcome Measures:
  • Occurence of anticipated and unanticipated adverse events [ Time Frame: Throughout the 6 weeks of the study ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
    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:
  • Temporal Gait Parameters of the 2 Minute Walk Test [ Time Frame: Week 1 and Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 and Week 6 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NESS L300 Plus System
    The patients will receive the device for daily use of six (6) weeks.
    Other Names:
    • NESS L300 Plus System
    • NESS L300
    • L300
    • L300 Plus
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01237860

Locations
Israel
Reuth Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Bioness Inc
Bioness Neuromodulation
Investigators
Principal Investigator: Jean-Jacques Vatine, MD Reuth Medical Center
  More Information

Publications:
Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT01237860     History of Changes
Other Study ID Numbers: 001 Rev 04
Study First Received: November 8, 2010
Last Updated: November 14, 2011
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by Bioness Inc:
Foot drop
Thigh muscle weakness
Upper Motor Neuron injury or disease

Additional relevant MeSH terms:
Asthenia
Muscle Weakness
Paresis
Wounds and Injuries
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014