Status:
UNKNOWN
Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Synapse Biomedical
Collaborating Sponsors:
University Hospitals Cleveland Medical Center
Johns Hopkins University
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18+ years
Phase:
NA
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 laparosc...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00420719
Start Date
October 1 2004
End Date
October 1 2009
Last Update
March 18 2009
Active Locations (8)
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1
Forbes Norris - California Pacific Medical Center (CPMC)
San Francisco, California, United States, 94115
2
Stanford University Medical Center
Stanford, California, United States, 94305
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287