Evaluation of the Safety and Performance of the NESS L300 Plus System

NCT ID: NCT01237860

Last Updated: 2011-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-01-31

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).

Conditions

Foot Drop; Thigh Muscles Weakness (Hamstrings or Quadriceps); Upper Motor Neuron Injury or Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

NESS L300 Plus System

The patients will receive the device for daily use of six (6) weeks.

Intervention Type: DEVICE

Other Intervention Names

NESS L300; L300; L300 Plus

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioness Neuromodulation

INDUSTRY

Sponsor Role: collaborator

Bioness Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Jacques Vatine, MD

Role: PRINCIPAL_INVESTIGATOR

Reuth Rehabilitation Hospital

Locations

Reuth Medical Center

Tel Aviv, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 9341692 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16731222 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8831470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15569875 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18158427 (View on PubMed)

Other Identifiers

001 Rev 04

Identifier Type: -

Identifier Source: org_study_id