Status:
COMPLETED
Evaluation of the Safety and Performance of the NESS L300 Plus System
Lead Sponsor:
Bioness Inc
Collaborating Sponsors:
Bioness Neuromodulation
Conditions:
Foot Drop
Thigh Muscles Weakness (Hamstrings or Quadriceps)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01237860
Start Date
September 1 2010
End Date
January 1 2011
Last Update
November 16 2011
Active Locations (1)
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1
Reuth Medical Center
Tel Aviv, Israel