Amyotrophic Lateral Sclerosis Clinical Trial
— RespiStimALSOfficial title:
Can Diaphragm Pacing Delay Non Invasive Ventilation in Amyotrophic Lateral Sclerosis ? a Randomized Controlled Study
Verified date | April 2015 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 74 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis is laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria - Forced Vital Capacity (FVC) from 80 - 60% of predicted values at enrollment - Bilateral phrenic nerve function acceptable as demonstrated by bilateral diaphragm EMG recordings and nerve conduction times without axonal lesion Exclusion Criteria: - Active cardiovascular disease that would increase the risk of general anesthesia. (FEVG<60%) - Underlying pulmonary diseases that were present prior to ALS that would effect pulmonary tests independent of ALS, in particular COPD with FEV1<30% - Pre-existing implanted electrical device such as a pacemaker or cardiac defibrillator - respiratory infection or decompensation in the last 30 days - Marked obesity affecting suitability for surgery - Significant scoliosis or chest deformity affecting suitability for surgery - Pre-existing diaphragm abnormality such as a hiatal hernia or paraesophageal hernia - Patient on NIV, CPAP or Oxygen for a reason other than ALS - Criteria for NIV (VC<50% of predicted values and/or Pi max and SNIP<60% of predicted values; and/or nocturnal desaturations without SAOS and/or PaCO2>45 mm d'Hg) - Supine VC<50% of predicted values |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | APHP, GH Pitié Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | ARSla (Association pour la recherche sur la SLA), Fondation Thierry Latran |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival without NIV 2 years after the phrenic nerve implantation. | 2 years | Yes | |
Secondary | global survival from onset disease | 2 years | No | |
Secondary | effects on sleep | 24 months | No | |
Secondary | Quality of life and daily activities | 24 months | No |
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