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

NCT01237860 | Completed Phase 3

• 1 other identifier: 001 Rev 04
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Occurence of anticipated and unanticipated adverse events

  The occurence of anticipated and unanticipated events will be documented at each scheduled evaluation. In addition, subjects will be instructed to report adverse events 24 hours per day during the study period.

  Throughout the 6 weeks of the study

• Subject feedback regarding the safety of using the device

  Patient feedback regarding the safety of using the device as reported during the study sessions and the completion of a satisfaction questionnaire will also be used to assess the system's safety.

  Week 6

Secondary Outcomes (2)

• Temporal Gait Parameters of the 2 Minute Walk Test

  Week 1 and Week 6

• 10 Meter Obstacle Course Walking Velocity

  Week 1 and Week 6

Interventions

NESS L300 Plus System DEVICE

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

Also known as: NESS L300, L300, L300 Plus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioness Inc: lead
• Bioness Neuromodulation: collaborator

Study Sites (1)

Reuth Medical Center

Tel Aviv, Israel

Location

Related Publications (5)

• 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.

  PMID: 9341692 BACKGROUND

• 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.

  PMID: 16731222 BACKGROUND

• 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.

  PMID: 8831470 BACKGROUND

• 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.

  PMID: 15569875 BACKGROUND

• 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.

  PMID: 18158427 BACKGROUND

MeSH Terms

Conditions

Peroneal Neuropathies; Disease

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Jean-Jacques Vatine, MD

  Reuth Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 10, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

IL (1)