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

Amyotrophic Lateral Sclerosis Clinical Trial

— PARADIGM  

Official title:

Multi-Center, Concurrent-Controlled, On-Label Study of the NeuRx Diaphragm Pacing System (DPS) in Participants With Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03034317
• Other study ID #: 20-1000-51
• Status: Withdrawn
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: February 12, 2018

Study information

• Verified date: March 2020
• Source: Synapse Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 12, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Synapse Biomedical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relationship between survival time and clinical features of ALS	Determine whether there is a relationship between survival time and ALS onset type.	24 months
Secondary	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.	24 months
Secondary	Relationship between survival time and onset of weakness from ALS to treatment		24 months
Secondary	Relationship between survival time and ALS treatment interventions		24 months
Secondary	Relationship between survival time and intraoperative strength of contraction		24 months
Secondary	Characterize change in overall and respiratory function	Characterize longitudinal change in overall function (ALSFRS-R) before and after treatment with DPS compared to controls.	24 months
Secondary	Characterize change in respiratory function	Characterize longitudinal change in respiratory function (FVC, MIP) before and after treatment with DPS compared to controls.	24 months
Secondary	Types device and procedure-related adverse events		24 months
Secondary	Frequency of device and procedure-related adverse events		24 months
Secondary	Types of respiratory serious adverse events		24 months
Secondary	Frequency of respiratory adverse events		24 months