Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)
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ClinicalTrials.gov Identifier: NCT00420719 |
Recruitment Status
: Unknown
Verified March 2009 by Synapse Biomedical.
Recruitment status was: Active, not recruiting
First Posted
: January 11, 2007
Last Update Posted
: March 18, 2009
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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 |

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 |

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Device: Intramuscular diaphragm electrodes
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420719
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 |
Principal Investigator: | Raymond Onders, MD | University Hospitals Cleveland Medical Center |
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 |
First Posted: | January 11, 2007 Key Record Dates |
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 |