Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Synapse Biomedical.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University Hospital Case Medical Center
Johns Hopkins University
Stanford University
Information provided by:
Synapse Biomedical
ClinicalTrials.gov Identifier:
NCT00420719
First received: January 9, 2007
Last updated: March 16, 2009
Last verified: March 2009
  Purpose

The overall goal of this research is to delay the respiratory decline of patients with Amyotrophic Lateral Sclerosis (ALS) thereby increasing their lifespan by conditioning the diaphragm with laparoscopically placed electrodes.

This device currently holds an Investigational Device Exemption No. G040142 in the United States and is currently undergoing clinical trials at University Hospitals (Cleveland), Johns Hopkins, Mayo Clinic Jacksonville, California Pacific Medical Center (CPMC), Henry Ford Health System, The Methodist Hospital, and Stanford University.


Condition Intervention
Amyotrophic Lateral Sclerosis (ALS)
Device: Intramuscular diaphragm electrodes

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center Pivotal Study of Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)

Resource links provided by NLM:


Further study details as provided by Synapse Biomedical:

Primary Outcome Measures:
  • The DPS System will slow the decline of pulmonary function, as defined by percent predicted forced vital capacity (FVC) to 30% of normal, by approximately 12 months [ Time Frame: After completion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events from implantation and use of the DPS System will be logged and qualitatively compared to adverse event rates in similar patient populations. [ Time Frame: After completion of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2004
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Intramuscular diaphragm electrodes
    Conditioning of the diaphragm
  Hide Detailed Description

Detailed Description:

The purpose of this study is to demonstrate the safety and efficacy of the NeuRX RA/4 Diaphragm Pacing Stimulation (DPS) System in conditioning the diaphragm of an ALS patient to improve the quality of life and slow the progression to respiratory failure.

Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease or Motor Neuron Disease) is a progressive neurodegenerative disease of unknown cause. One of the most important effects of progressive neuromuscular weakness in patients with ALS is the effect on respiration. Although ALS has no direct effect on the lung, it has devastating effects on mechanical function of the respiratory system. ALS affects all of the major respiratory muscle groups: upper airway muscles, expiratory muscles, and inspiratory muscles. Therefore, all patients with ALS are at significant risk for respiratory complications. Progressive inspiratory muscle weakness in ALS inevitably leads to carbon dioxide retention, inability to clear secretions and hypercarbic respiratory failure, the major cause of death in ALS.

Synapse Biomedical, in conjunction with Case Western Reserve University and University Hospitals of Cleveland, have evaluated activating the diaphragm with percutaneous intramuscular electrodes implanted laparoscopically. This eliminates any direct contact with the phrenic nerve, allows all circuitry and electronics to remain outside the body, and provides direct, selective activation to each hemidiaphragm. The NeuRx-RA/4 DPS System provides an electrical signal to the motor point of the muscle that causes the diaphragm to contract and allows patients to breathe more naturally.

The NeuRx RA/4 DPS System has been implanted in over 10 individuals with ALS, in a pilot study at the University Hospitals of Cleveland that began January, 2005.

The NeuRx RA/4 DPS System platform, also used for respiratory support for individuals with high-level spinal cord injury, has over 56 years of cumulative active implantation time. The longest term patient was implanted March 6, 2000 and has been using the DPS System as his sole means of respiratory support for over six years.

Given patient results to date the data supports safety and efficacy to proceed to pivotal study in this patient population. With no unexpected significant adverse events reported, the NeuRx RA/4 DPS System has performed reliably and safely.

Device Description: The NeuRx RA/4 Respiratory System is manufactured by Synapse Biomedical. The NeuRx RA/4 System comprises the following components: an external, battery powered Stimulator Device, an associated Programmer/Controller, Intramuscular Electrodes, associated percutaneous Lead Wires, a Surgical Placement Tool Set, and a surgical Mapping Station.

Inclusion Criteria:

  • Age 18 or older
  • Participants with familial or sporadic ALS diagnosed as laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria will be eligible
  • Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with EMG recordings and nerve conduction times
  • Forced Vital Capacity (FVC) between 50 - 85% of predicted values to begin screening procedures.
  • FVC greater than 45% of predicted value at time of surgery.
  • No underlying cardiac or pulmonary diseases that would increase the risk of general anesthesia greater than the expected risk of the patient with ALS
  • Negative pregnancy test in females of child-bearing potential
  • Informed consent from patient or designated representative

Exclusion Criteria:

  • Preexisting implanted electrical device such as pacemaker or cardiac defibrillator.
  • Underlying pulmonary diseases that were present prior to ALS that would effect pulmonary tests independent of ALS.
  • Active cardiovascular disease that would increase the risk of general anesthesia
  • Current pregnancy or breastfeeding
  • Hospitalization for a treated active infection within the last 2 months
  • Significant decision making incapacity preventing informed consent by the subject due to a major mental disorder such as major depression or schizophrenia, or dementia such as having Alzheimer's disease.
  • Marked obesity
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Participants with familial or sporadic ALS diagnosed as laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria will be eligible
  • Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with EMG recordings and nerve conduction times
  • Forced Vital Capacity (FVC) between 50 - 85% of predicted values to begin screening procedures.
  • FVC greater than 45% of predicted value at time of surgery.
  • No underlying cardiac or pulmonary diseases that would increase the risk of general anesthesia greater than the expected risk of the patient with ALS
  • Negative pregnancy test in females of child-bearing potential
  • Informed consent from patient or designated representative

Exclusion Criteria:

  • Preexisting implanted electrical device such as pacemaker or cardiac defibrillator.
  • Underlying pulmonary diseases that were present prior to ALS that would effect pulmonary tests independent of ALS
  • Active cardiovascular disease that would increase the risk of general anesthesia
  • Current pregnancy or breastfeeding
  • Hospitalization for a treated active infection within the last 2 months
  • Significant decision making incapacity preventing informed consent by the subject due to a major mental disorder such as major depression or schizophrenia, or dementia such as having Alzheimer's disease.
  • Marked obesity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420719

Locations
United States, California
Forbes Norris - California Pacific Medical Center (CPMC)
San Francisco, California, United States, 94115
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202-2689
United States, Ohio
University Hospitals Of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
France
Groupe Hospitalier Pitie-Salpetriere
Paris, France
Sponsors and Collaborators
Synapse Biomedical
University Hospital Case Medical Center
Johns Hopkins University
Stanford University
Investigators
Principal Investigator: Raymond Onders, MD University Hospital Case Medical Center
  More Information

No publications provided by Synapse Biomedical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raymond Onders, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00420719     History of Changes
Other Study ID Numbers: CLIN 20-0009-0005
Study First Received: January 9, 2007
Last Updated: March 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Synapse Biomedical:
ALS
Amyotrophic Lateral Sclerosis
Lou Gehrig's disease
Diaphragm for Ventilatory Assist
Diaphragm Pacing

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on October 23, 2014