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
Recruitment status was Active, not recruiting
Sponsor:
Synapse Biomedical
Collaborators:
University Hospitals Cleveland 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
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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:
Genetics Home Reference related topics:
amyotrophic lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
U.S. FDA Resources
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
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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 Hospitals Cleveland Medical Center
Johns Hopkins University
Stanford University
Investigators
| Principal Investigator: | Raymond Onders, MD | University Hospitals Cleveland Medical Center |
More Information
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:
|
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 |
ClinicalTrials.gov processed this record on September 23, 2016