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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Amyotrophic Lateral Sclerosis (ALS)	Device: Intramuscular diaphragm electrodes	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Intervention Model:	Single Group Assignment
Masking:	None (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)
Study Start Date :	October 2004
Estimated Primary Completion Date :	October 2009
Estimated Study Completion Date :	October 2009

Arms and Interventions

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Intervention Details:

Device: Intramuscular diaphragm electrodes
Conditioning of the diaphragm

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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 Hospitals Cleveland Medical Center

Johns Hopkins University

Stanford University

Investigators

Principal Investigator:	Raymond Onders, MD	University Hospitals Cleveland Medical Center

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gonzalez-Bermejo J, Morélot-Panzini C, Salachas F, Redolfi S, Straus C, Becquemin MH, Arnulf I, Pradat PF, Bruneteau G, Ignagni AR, Diop M, Onders R, Nelson T, Menegaux F, Meininger V, Similowski T. Diaphragm pacing improves sleep in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012 Jan;13(1):44-54. doi: 10.3109/17482968.2011.597862. Epub 2011 Oct 24.

Responsible Party:	Raymond Onders, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00420719 History of Changes
Other Study ID Numbers:	CLIN 20-0009-0005
First Posted:	January 11, 2007
Last Update Posted:	March 18, 2009
Last Verified:	March 2009

Keywords provided by Synapse Biomedical:

ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig's disease; Diaphragm for Ventilatory Assist; Diaphragm Pacing

Additional relevant MeSH terms:

Sclerosis; Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases	Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases