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Device

NeuRx® Diaphragm Pacing System™ (DPS) for Lou Gehrig's Disease (DPS in ALS Trial)

Phase 2
Waitlist Available
Led By Jeremy Shefner, MD, PhD
Research Sponsored by Barrow Neurological Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects will be assessed on a monthly basis for an 18 month period.
Awards & highlights

DPS in ALS Trial Summary

The study is being conducted to determine if DPS treatment for people with ALS and hypoventilation is associated with improved survival or diaphragm function. The primary objective of the study is to conduct a multi-center, randomized controlled clinical trial comparing standard of care (control) to diaphragm stimulator treatment with the NeuRx® Diaphragm Pacing System™ (DPS) with respect to survival. The secondary objective of the study is to conduct a multi-center, randomized controlled clinical trial to compare standard of care treatment (control) to DPS in ALS subjects with hypoventilation.

Eligible Conditions
  • Lou Gehrig's Disease

DPS in ALS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects will be assessed on a monthly basis for an 18 month period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will be assessed on a monthly basis for an 18 month period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survival
Secondary outcome measures
quality of life

DPS in ALS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NeuRx® Diaphragm Pacing System™ (DPS)Experimental Treatment1 Intervention
Patients randomized to the experimental arm will receive The NeuRx® Diaphragm Pacing System™ (DPS) device. Under general anesthesia, the intramuscular electrodes are surgically implanted in the diaphragm.
Group II: Standard of CareActive Control1 Intervention
patients randomized to the standard of care arm will not have the Diaphragm Pacing System surgically implanted but will receive standard medical care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NeuRx® Diaphragm Pacing System™ (DPS)
2013
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Barrow Neurological InstituteLead Sponsor
24 Previous Clinical Trials
7,011 Total Patients Enrolled
Muscular Dystrophy AssociationOTHER
36 Previous Clinical Trials
60,379 Total Patients Enrolled
Synapse BiomedicalIndustry Sponsor
10 Previous Clinical Trials
352 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)
Jeremy Shefner 2013. "Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01938495.
~4 spots leftby Apr 2025
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