Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420719
Status:
UNKNOWN
Last Update Posted:
2009-03-18
First Post:
2007-01-09
Brief Title:
Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis ALS
Sponsor:
Synapse Biomedical
Organization:
Synapse Biomedical
Study Overview
Official Title:
Multi-Center Pivotal Study of Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis ALS
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
The purpose of this study is to demonstrate the safety and efficacy of the NeuRX RA4 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 Gehrigs 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-RA4 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 RA4 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 RA4 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 RA4 DPS System has performed reliably and safely
Device Description The NeuRx RA4 Respiratory System is manufactured by Synapse Biomedical The NeuRx RA4 System comprises the following components an external battery powered Stimulator Device an associated ProgrammerController 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 Alzheimers disease
Marked obesity
Amyotrophic Lateral Sclerosis ALS also known as Lou Gehrigs 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-RA4 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 RA4 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 RA4 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 RA4 DPS System has performed reliably and safely
Device Description The NeuRx RA4 Respiratory System is manufactured by Synapse Biomedical The NeuRx RA4 System comprises the following components an external battery powered Stimulator Device an associated ProgrammerController 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 Alzheimers disease
Marked obesity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None