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NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS) (PARADIGM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03034317
Recruitment Status : Unknown
Verified January 2017 by Synapse Biomedical.
Recruitment status was:  Not yet recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Synapse Biomedical

Brief Summary:
The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: NeuRx DPS Not Applicable

Detailed Description:
Characterize the safety and benefit of on-label Humanitarian Device Exemption (HDE) use of DPS in patients with ALS who initiated noninvasive ventilation (NIV).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Multi-Center, Concurrent-Controlled, On-Label Study of the NeuRx Diaphragm Pacing System (DPS) in Participants With Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : February 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Active Comparator: NeuRx DPS
Subjects who have initiated noninvasive ventilation (NIV) and receive the NeuRx diaphragm pacing system (DPS).
Device: NeuRx DPS
Patients who are diagnosed with ALS, have initiated NIV and choose to have the NeuRx DPS implanted.
Other Name: Diaphragm Pacing System

No Intervention: No DPS
Subjects who have initiated noninvasive ventilation (NIV) and do not receive the DPS device.



Primary Outcome Measures :
  1. Survival [ Time Frame: 24 months ]
    Compare the survival of patients who initiated noninvasive ventilation (NIV).and who receive DPS to controls without DPS: (1) concurrent controls; (2) historical controls (e.g., Lechtzin and PRO-ACT databases); and (3) virtual controls (Origent).


Secondary Outcome Measures :
  1. Relationship between survival time and clinical features of ALS [ Time Frame: 24 months ]
    Determine whether there is a relationship between survival time and ALS onset type.

  2. Relationship between survival time and ALS assessment scores [ Time Frame: 24 months ]
    Determine whether there is a relationship between survival time and Upper Motor Neuron (UMN)/ Lower Motor Neuron (LMN) assessment scores.

  3. Relationship between survival time and onset of weakness from ALS to treatment [ Time Frame: 24 months ]
  4. Relationship between survival time and ALS treatment interventions [ Time Frame: 24 months ]
  5. Relationship between survival time and intraoperative strength of contraction [ Time Frame: 24 months ]
  6. Characterize change in overall and respiratory function [ Time Frame: 24 months ]
    Characterize longitudinal change in overall function (ALSFRS-R) before and after treatment with DPS compared to controls.

  7. Characterize change in respiratory function [ Time Frame: 24 months ]
    Characterize longitudinal change in respiratory function (FVC, MIP) before and after treatment with DPS compared to controls.

  8. Types device and procedure-related adverse events [ Time Frame: 24 months ]
  9. Frequency of device and procedure-related adverse events [ Time Frame: 24 months ]
  10. Types of respiratory serious adverse events [ Time Frame: 24 months ]
  11. Frequency of respiratory adverse events [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 or older
  • Familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria
  • Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with phrenic nerve conduction studies
  • Chronic hypoventilation was documented by at least one of the following:

    • MIP (respiratory muscle strength) less than 60 cmH2O, or
    • Forced Vital Capacity (FVC) less than 50% predicted, or
    • PaCO2 greater than or equal to 45 mmHg, or
    • Nocturnal SaO2 (arterial oxygen saturation) less than or equal to 88% for at least five continuous minutes
  • Initiation of non-invasive ventilation at or before time of enrollment
  • Suitable surgical candidate to receive diaphragm pacing stimulation
  • Negative pregnancy test in female participants of childbearing potential (treatment group)
  • Informed consent from patient or designated representative

Exclusion Criteria:

  • FVC less than 45% predicted within 10 days prior to surgery.
  • Participation in simultaneous therapeutic clinical trial which could affect the safety or benefit outcomes of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034317


Contacts
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Contact: Jeff Thompson 440-774-2488 ext 121 jthompson@synapsebiomedical.com
Contact: Michael Fritz 440-774-2488 ext 134 mfritz@synapsebiomedical.com

Sponsors and Collaborators
Synapse Biomedical
Investigators
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Principal Investigator: Robert Miller, MD California Pacific Medical Center

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Responsible Party: Synapse Biomedical
ClinicalTrials.gov Identifier: NCT03034317     History of Changes
Other Study ID Numbers: 20-1000-51
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Synapse Biomedical:
Diaphragm Pacing

Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases