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Early Stage Amyotrophic Lateral Sclerosis Phrenic Stimulation

NCT01583088 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-12-22

No results posted yet for this study

Summary

ALS is is characterized by a progressive degeneration of motor neurons, leading to progressive weakness of muscles, including respiratory muscles, the diaphragm. Although specific therapy is lacking, correct respiratory therapy improves quality of life and increases survival. Substituting the failing respiratory muscles by non invasive mechanical ventilatory assistance (NIV) is the current standard of care. Intradiaphragmatic phrenic nerve stimulation is a new treatment and has been the object of a preliminary international proof-of-concept multicenter trial. This trial suggests that the intradiaphragmatic phrenic nerve stimulation slows down the rate of decline of the diaphragm. Our new hypothesis is that phrenic stimulation induces diaphragm conditioning and can delay the need for mechanical ventilation in ALS patients. We will study, during 24 months, 2 groups of 37 patients at the beginning of the respiratory dysfunction, using a intradiaphragmatic phrenic nerve stimulation in one group and a sham stimulation in the other group. Although, all the patients will be implanted, thus, at the end of the study, all the patients will receive effective stimulation.

Conditions

Interventions

DEVICE

phenique nerve stimulation NeurX™ (Synapse Biomedical)

phenique nerve stimulation NeurX™ (Synapse Biomedical)

DEVICE

sham phrenic nerve stimulation

sham phenic nerve stimulation

Sponsors & Collaborators

  • ARSla (Association pour la recherche sur la SLA)

    collaborator UNKNOWN

  • Fondation Thierry Latran

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Gonzalez-Bermejo Jesus, Md, PhD · APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583088 on ClinicalTrials.gov