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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NeuRx DPS
Sponsored by
Synapse Biomedical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Diaphragm Pacing

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    NeuRx DPS

    No DPS

    Arm Description

    Subjects who have initiated noninvasive ventilation (NIV) and receive the NeuRx diaphragm pacing system (DPS).

    Subjects who have initiated noninvasive ventilation (NIV) and do not receive the DPS device.

    Outcomes

    Primary Outcome Measures

    Survival
    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

    Relationship between survival time and clinical features of ALS
    Determine whether there is a relationship between survival time and ALS onset type.
    Relationship between survival time and ALS assessment scores
    Determine whether there is a relationship between survival time and Upper Motor Neuron (UMN)/ Lower Motor Neuron (LMN) assessment scores.
    Relationship between survival time and onset of weakness from ALS to treatment
    Relationship between survival time and ALS treatment interventions
    Relationship between survival time and intraoperative strength of contraction
    Characterize change in overall and respiratory function
    Characterize longitudinal change in overall function (ALSFRS-R) before and after treatment with DPS compared to controls.
    Characterize change in respiratory function
    Characterize longitudinal change in respiratory function (FVC, MIP) before and after treatment with DPS compared to controls.
    Types device and procedure-related adverse events
    Frequency of device and procedure-related adverse events
    Types of respiratory serious adverse events
    Frequency of respiratory adverse events

    Full Information

    First Posted
    January 13, 2017
    Last Updated
    March 24, 2020
    Sponsor
    Synapse Biomedical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03034317
    Brief Title
    NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS)
    Acronym
    PARADIGM
    Official Title
    Multi-Center, Concurrent-Controlled, On-Label Study of the NeuRx Diaphragm Pacing System (DPS) in Participants With Amyotrophic Lateral Sclerosis (ALS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolled
    Study Start Date
    February 2, 2017 (Actual)
    Primary Completion Date
    February 8, 2018 (Actual)
    Study Completion Date
    February 12, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Synapse Biomedical

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amyotrophic Lateral Sclerosis
    Keywords
    Diaphragm Pacing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Masking Description
    Open label
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NeuRx DPS
    Arm Type
    Active Comparator
    Arm Description
    Subjects who have initiated noninvasive ventilation (NIV) and receive the NeuRx diaphragm pacing system (DPS).
    Arm Title
    No DPS
    Arm Type
    No Intervention
    Arm Description
    Subjects who have initiated noninvasive ventilation (NIV) and do not receive the DPS device.
    Intervention Type
    Device
    Intervention Name(s)
    NeuRx DPS
    Other Intervention Name(s)
    Diaphragm Pacing System
    Intervention Description
    Patients who are diagnosed with ALS, have initiated NIV and choose to have the NeuRx DPS implanted.
    Primary Outcome Measure Information:
    Title
    Survival
    Description
    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).
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Relationship between survival time and clinical features of ALS
    Description
    Determine whether there is a relationship between survival time and ALS onset type.
    Time Frame
    24 months
    Title
    Relationship between survival time and ALS assessment scores
    Description
    Determine whether there is a relationship between survival time and Upper Motor Neuron (UMN)/ Lower Motor Neuron (LMN) assessment scores.
    Time Frame
    24 months
    Title
    Relationship between survival time and onset of weakness from ALS to treatment
    Time Frame
    24 months
    Title
    Relationship between survival time and ALS treatment interventions
    Time Frame
    24 months
    Title
    Relationship between survival time and intraoperative strength of contraction
    Time Frame
    24 months
    Title
    Characterize change in overall and respiratory function
    Description
    Characterize longitudinal change in overall function (ALSFRS-R) before and after treatment with DPS compared to controls.
    Time Frame
    24 months
    Title
    Characterize change in respiratory function
    Description
    Characterize longitudinal change in respiratory function (FVC, MIP) before and after treatment with DPS compared to controls.
    Time Frame
    24 months
    Title
    Types device and procedure-related adverse events
    Time Frame
    24 months
    Title
    Frequency of device and procedure-related adverse events
    Time Frame
    24 months
    Title
    Types of respiratory serious adverse events
    Time Frame
    24 months
    Title
    Frequency of respiratory adverse events
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Miller, MD
    Organizational Affiliation
    California Pacific Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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