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

Bioness

Status and phase

Completed

Phase 3

Conditions

Upper Motor Neuron Injury or Disease

Foot Drop

Thigh Muscles Weakness (Hamstrings or Quadriceps)

Treatments

Device: NESS L300 Plus System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01237860

001 Rev 04

Details and patient eligibility

About

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.

Full 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).

Enrollment

45 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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