Evaluation of the Safety and Performance of the NESS L300 Plus System (NCT01237860) | Clinical Trial Compass
CompletedPhase 3
Evaluation of the Safety and Performance of the NESS L300 Plus System
Israel45 participantsStarted 2010-09
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 di…
What they're measuring
1
Occurence of anticipated and unanticipated adverse events
Timeframe: Throughout the 6 weeks of the study
2
Subject feedback regarding the safety of using the device