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

NCT00420719 | Unknown

• 1 other identifier: CLIN 20-0009-0005
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 8

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

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

Outcome Measures

Primary Outcomes (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

  After completion of the study

Secondary Outcomes (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.

  After completion of the study

Interventions

Intramuscular diaphragm electrodes DEVICE

Conditioning of the diaphragm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Synapse Biomedical: lead
• University Hospitals Cleveland Medical Center: collaborator
• Johns Hopkins University: collaborator
• Stanford University: collaborator

Study Sites (8)

Forbes Norris - California Pacific Medical Center (CPMC)

San Francisco, California, 94115, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202-2689, United States

Location

University Hospitals Of Cleveland

Cleveland, Ohio, 44106, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, France

Location

Related Publications (1)

• Gonzalez-Bermejo J, Morelot-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.

  PMID: 22023158 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Raymond Onders, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: October 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 18, 2009

Record last verified: 2009-03

Locations

FR (1); US (7)