Clinical trial NCT01237860: Evaluation of the Safety and Performance of the NESS L300 Plus System
Official title: Evaluation of the Safety and Performance of the NESS L300 Plus System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Foot Drop
Thigh Muscles Weakness (Hamstrings or Quadriceps)
Upper Motor Neuron Injury or Disease
Keywords: Foot drop
Thigh muscle weakness
Upper Motor Neuron injury or disease
Lead sponsor: Bioness Inc
Sponsor class: INDUSTRY
Collaborators: name: Bioness Neuromodulation
First posted: 2010-11-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Occurence of anticipated and unanticipated adverse events
timeFrame: Throughout the 6 weeks of the study
measure: Subject feedback regarding the safety of using the device
timeFrame: Week 6
Secondary outcomes:
measure: Temporal Gait Parameters of the 2 Minute Walk Test
timeFrame: Week 1 and Week 6
measure: 10 Meter Obstacle Course Walking Velocity
timeFrame: Week 1 and Week 6
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Reuth Medical Center
Study officials:
affiliation: Reuth Rehabilitation Hospital
name: Jean-Jacques Vatine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonita R, Solomon N, Broad JB. Prevalence of stroke and stroke-related disability. Estimates from the Auckland stroke studies. Stroke. 1997 Oct;28(10):1898-902. doi: 10.1161/01.str.28.10.1898.
citation: Robbins SM, Houghton PE, Woodbury MG, Brown JL. The therapeutic effect of functional and transcutaneous electric stimulation on improving gait speed in stroke patients: a meta-analysis. Arch Phys Med Rehabil. 2006 Jun;87(6):853-9. doi: 10.1016/j.apmr.2006.02.026.
citation: Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2.
citation: Yan T, Hui-Chan CW, Li LS. Functional electrical stimulation improves motor recovery of the lower extremity and walking ability of subjects with first acute stroke: a randomized placebo-controlled trial. Stroke. 2005 Jan;36(1):80-5. doi: 10.1161/01.STR.0000149623.24906.63. Epub 2004 Nov 29.
citation: Hausdorff JM, Ring H. Effects of a new radio frequency-controlled neuroprosthesis on gait symmetry and rhythmicity in patients with chronic hemiparesis. Am J Phys Med Rehabil. 2008 Jan;87(1):4-13. doi: 10.1097/PHM.0b013e31815e6680.