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

Status unconfirmed · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

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.

Key facts

Study ID

NCT00420719

Run by

Synapse Biomedical

People needed

100

Starts

2004-10-01

Expected to finish

2009-10-01

Last updated by the study team

2009-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forbes Norris - California Pacific Medical Center (CPMC) — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University Hospitals Of Cleveland — Cleveland, Ohio, United States
• The Methodist Hospital — Houston, Texas, United States
• Groupe Hospitalier Pitie-Salpetriere — Paris, France

Full record on ClinicalTrials.gov

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