NCT03034317

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

January 13, 2017

Last Update Submit

March 24, 2020

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Diaphragm Pacing

Outcome Measures

Primary Outcomes (1)

  • 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).

    24 months

Secondary Outcomes (11)

  • Relationship between survival time and clinical features of ALS

    24 months

  • Relationship between survival time and ALS assessment scores

    24 months

  • Relationship between survival time and onset of weakness from ALS to treatment

    24 months

  • Relationship between survival time and ALS treatment interventions

    24 months

  • Relationship between survival time and intraoperative strength of contraction

    24 months

  • +6 more secondary outcomes

Study Arms (2)

NeuRx DPS

ACTIVE COMPARATOR

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

Device: NeuRx DPS

No DPS

NO INTERVENTION

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

Interventions

NeuRx DPSDEVICE

Patients who are diagnosed with ALS, have initiated NIV and choose to have the NeuRx DPS implanted.

Also known as: Diaphragm Pacing System
NeuRx DPS

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Robert Miller, MD

    California Pacific Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 27, 2017

Study Start

February 2, 2017

Primary Completion

February 8, 2018

Study Completion

February 12, 2018

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share