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Home » Clinical Trials » Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details

Overview

Research Study Summary

A clinical research study of NeuRx Diaphragm Pacing System (DPS) for the treatment of Amyotrophic Lateral Sclerosis (ALS)

Research Study Title

HDE Post-Approval Study (PAS) of NeuRx DPS for ALS

Purpose

This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who are successfully implanted with the device will use it for daily diaphragm conditioning sessions. Participants will be followed for at least two years (until the last enrolled participant reaches the 2-year follow-up visit). Safety and probable benefit outcome measures will be assessed.

To Learn more
Gender

Both Male and Female

Age

21 and up

Overall Status

Recruiting

Lead Sponsor

Synapse Biomedical

Duration

62 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 21 Years and up

Inclusion Criteria:

  1. Age 21 or older.

  2. Participants with familial or sporadic ALS diagnosed as laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria.

  3. Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with EMG recordings and nerve conduction times.

  4. Chronic hypoventilation was documented by at least one of the following:

  5. FVC less than 50% predicted, or

  6. /MIP/ less than 60 cmH2O, or

  7. PaCO2 greater than or equal to 45 mmHg, or

  8. Nocturnal SaO2 less than or equal to 88% for at least five continuous minutes

  9. Suitable surgical candidate.

  10. Negative pregnancy test in female participants of childbearing potential.

  11. Informed consent from patient or designated representative.

Exclusion Criteria:

  1. Underlying cardiac or pulmonary disease that would increase the risk of general anesthesia.

  2. Underlying pulmonary diseases that were present prior to ALS that would affect pulmonary tests independent of ALS.

  3. Uncontrolled excessive secretions.

  4. FVC less than 45% predicted at time of surgery.

  5. Preexisting implanted electrical device such as pacemaker or cardiac defibrillator.

  6. Pre-existing diaphragm abnormality such as a hiatal hernia or paraesophageal hernia of abdominal contents going into the thoracic cavity.

Site Locations (1)

Country State City Zip Facility and Contact
United States California San Francisco 94115 California Pacific Medical Center -- Forbes Norris MDA/ALS Research Center
Robert G. Miller, M.D.
415-600-3604
MillerRX@cpmcri.org

Robert G. Miller, M.D.
Principal Investigator

Contact

Michael Fritz
888-767-3770 ext. 134

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01605006

Date Last Changed: August 24, 2012

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