Spinal Cord InjuryNCT00010374
Electrical Activation of The Diaphragm for Ventilatory Assist
A study testing NeuRx DPS in people with Spinal Cord Injury and Quadriplegia, run by Synapse Biomedical at 5 sites in 2 countries.
Trial summary
OBJECTIVES: The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Quadriplegia
- What is being tested?
- NeuRx DPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Feb 2000to Oct 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Cervical spinal cord injury dependent on mechanical ventilation
- Clinically stable following acute spinal cord injury
- Bilateral phrenic nerve function clinically acceptable as demonstrated with EMG recordings and nerve conduction times
- Diaphragm movement with stimulation visible under fluoroscopy
- Clinically acceptable oxygenation on room air (>90%)
Show all 11Show fewer
- Hemodynamically stable
- No medical co-morbidities that would interfere with the proper placement or function of the device
- Committed primary caregiver
- Negative pregnancy test in females of child-bearing potential
- Informed consent from patient or designated representative
Who cannot join
- Co-morbid medical conditions that preclude surgery
- Active lung disease (obstructive, restrictive or membrane diseases)
- Active cardiovascular disease
- Active brain disease
- Hemodynamic instability or low oxygen levels on room air
- Hospitalization for or a treated active infection within the last 3 months
Show all 10Show fewer
- Significant scoliosis or chest deformity
- Marked obesity
- Anticipated poor compliance with protocol by either patient or primary caregiver
- Currently breastfeeding
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Shepherd Center
Atlanta, Georgia, 30309-1465
University Hospital Of Cleveland
Cleveland, Ohio, 44106
Craig Hospital
Englewood, Colorado, 80113-2811
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Multi-Center Pivotal Study of NeuRx RA/4 Ventilatory Assist Device
OBJECTIVES:
The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The hypothesis being tested in the clinical trial is that laparoscopic stimulation of the diaphragm at the motor point with intramuscular electrodes is safe and effective in providing significant ventilatory support to individuals who are otherwise dependant on a mechanical ventilator. Patients in our initial study group have all suffered from high-level spinal cord injury and were full-time dependant on positive pressure mechanical ventilation prior to inclusion.
Read the detailed description
System: NeuRx RA/4 Diaphragm Pacing Stimulation System
Summary:
The NeuRx-RA/4 is intended to be used by individuals that have sustained a spinal cord injury, requiring aid with respiration. The device connects to the diaphragm which delivers current to stimulate muscle contractions to aid in respirations.
This device currently holds an Investigational Device Exemption No. G920162 in the United States and is currently undergoing clinical trials at University Hospitals (Cleveland), Shepherd Center (Atlanta) and Vancouver (Canada).
Introduction:
The purpose of the study is to determine if a new, investigational diaphragm pacing system can provide part or full time respiratory support to spinal cord injured persons who normally need a mechanical ventilator. Patients with high-level spinal cord injuries typically experience chronic ventilatory insufficiency due to respiratory muscle paralysis; these patients must be supported predominantly through positive pressure mechanical ventilation with a ventilator.
The diaphragm pacing system (NeuRx-RA/4) provides an electrical signal to the motor point of the muscle that causes the diaphragm to contract and allows patients to breathe more naturally.
Synapse Biomedical, in conjunction with Case Western Reserve University and University Hospitals of Cleveland, are evaluating activating the diaphragm with percutaneous intramuscular electrodes implanted laparoscopically. This eliminates any direct contact with the phrenic nerve, allows all circuitry and electronics to remain outside the body, and provides direct, selective activation to each hemidiaphragm.
The NeuRx RA/4 Diaphragm Pacing Stimulation (DPS) System has been implanted in 49 individuals with high-level spinal cord injury, resulting in over 20 years of cumulative active implantation time. The longest term patient was implanted March 6, 2000 and has been using the DPS System as his sole means of respiratory support for over five years. With the exception of the second patient, who does not meet our revised inclusion criteria and has gained no benefit from the implant, all of the remaining patients have been able to achieve significant tidal volumes with the DPS System. Based on the current results, the NeuRx RA/4 DPS System has demonstrated safety and efficacy in patients with high-level spinal cord injury.
Given the results to date the study has demonstrated preliminary efficacy in this patient population. With no unexpected significant adverse events reported the NeuRx RA/4 DPS System has performed reliably and safely in this patient population.
Device Description: The NeuRx RA/4 Respiratory System is manufactured by Synapse Biomedical. The NeuRx RA/4 System comprises the following components: an external, battery powered Stimulator Device, an associated Programmer/Controller, Intramuscular Electrodes, associated percutaneous Lead Wires, a Surgical Placement Tool Set, and a surgical Mapping Station.
Inclusion Criteria:
- Age 18 years or older
- Cervical spinal cord injury dependent on mechanical ventilation
- Clinically stable following acute spinal cord injury
- Bilateral phrenic nerve function clinically acceptable as demonstrated with EMG recordings and nerve conduction times
- Diaphragm movement with stimulation visible under fluoroscopy
- Clinically acceptable oxygenation on room air (>90%)
- Hemodynamically stable
- No medical co-morbidities that would interfere with the proper placement or function of the device
- Committed primary caregiver
- Negative pregnancy test in females of child-bearing potential
- Informed consent from patient or designated representative
Exclusion Criteria:
- Co-morbid medical conditions that preclude surgery
- Active lung disease (obstructive, restrictive or membrane diseases)
- Active cardiovascular disease
- Active brain disease
- Hemodynamic instability or low oxygen levels on room air
- Hospitalization for or a treated active infection within the last 3 months
- Significant scoliosis or chest deformity
- Marked obesity
- Anticipated poor compliance with protocol by either patient or primary caregiver.
- Currently breastfeeding
- Conditions
- Spinal Cord Injury, Quadriplegia
- Being tested
- NeuRx DPS
- Keywords
- Diaphragm for Ventilatory Assist, environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuRx DPSDevice
Laparoscopic implantation of diaphragm electrodes and subsequent pacing with the NeuRx DPS.
| Study group | Role | What they receive |
|---|---|---|
| NeuRx DPS | Experimental | Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system. Receives: Device: NeuRx DPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period.
Number of enrolled subjects that successfully maintained clinically acceptable tidal volumes greater than basal requirements over a continuous 4 hour period.
Measured: Within one year after implantation
Secondary outcomes (2)
Achieve Clinically Acceptable Basal Metabolic Requirement of Tidal Volume Measured in ml During Chronic Stimulation.
To evaluate the ability of NeuRx DPS therapy to replace mechanical ventilation for patients on a chronic use basis, a secondary indicator of this objective is tidal volume (Vt) measured in ml during chronic stimulation.
Measured: Within one year after implantation
Number of Patients That Use NeuRx DPS to Breathe Without the Assistance of a Mechanical Ventilator for 24 Continuous Hours a Day
Number of patients that can achieve at least 24 hours daily use of the NeuRx DPS without the assistance of a mechanical ventilator.
Measured: Within one year of implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2001 (estimated)
- Study startFeb 2000
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synapse Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center, Shepherd Center, Atlanta GA
- Responsible party
- Sponsor
- Investigators
- Raymond Onders, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010374
- Sponsor's protocol ID
- CLIN 20-0000-0009
- Status last verified
- Aug 2020
- First submitted
- 2 Feb 2001
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Pivotal Study of NeuRx RA/4 Ventilatory Assist Device
- ClinicalTrials.gov ID
- NCT00010374
- Acronym / sponsor ID
- CLIN 20-0000-0009
- Conditions
- Spinal Cord Injury, Quadriplegia
- Keywords
- Diaphragm for Ventilatory Assist, environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Synapse BiomedicalIndustry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center, Shepherd Center, Atlanta GA
- Study start
- Feb 2000
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 2 Feb 2001 (estimated)
- Results
- Posted 15 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The hypothesis being tested in the clinical trial is that laparoscopic stimulation of the diaphragm at the motor point with intramuscular electrodes is safe and effective in providing significant ventilatory support to individuals who are otherwise dependant on a mechanical ventilator. Patients in our initial study group have all suffered from high-level spinal cord injury and were full-time dependant on positive pressure mechanical ventilation prior to inclusion.
Detailed description
System: NeuRx RA/4 Diaphragm Pacing Stimulation System
Summary:
The NeuRx-RA/4 is intended to be used by individuals that have sustained a spinal cord injury, requiring aid with respiration. The device connects to the diaphragm which delivers current to stimulate muscle contractions to aid in respirations.
This device currently holds an Investigational Device Exemption No. G920162 in the United States and is currently undergoing clinical trials at University Hospitals (Cleveland), Shepherd Center (Atlanta) and Vancouver (Canada).
Introduction:
The purpose of the study is to determine if a new, investigational diaphragm pacing system can provide part or full time respiratory support to spinal cord injured persons who normally need a mechanical ventilator. Patients with high-level spinal cord injuries typically experience chronic ventilatory insufficiency due to respiratory muscle paralysis; these patients must be supported predominantly through positive pressure mechanical ventilation with a ventilator.
The diaphragm pacing system (NeuRx-RA/4) provides an electrical signal to the motor point of the muscle that causes the diaphragm to contract and allows patients to breathe more naturally.
Synapse Biomedical, in conjunction with Case Western Reserve University and University Hospitals of Cleveland, are evaluating activating the diaphragm with percutaneous intramuscular electrodes implanted laparoscopically. This eliminates any direct contact with the phrenic nerve, allows all circuitry and electronics to remain outside the body, and provides direct, selective activation to each hemidiaphragm.
The NeuRx RA/4 Diaphragm Pacing Stimulation (DPS) System has been implanted in 49 individuals with high-level spinal cord injury, resulting in over 20 years of cumulative active implantation time. The longest term patient was implanted March 6, 2000 and has been using the DPS System as his sole means of respiratory support for over five years. With the exception of the second patient, who does not meet our revised inclusion criteria and has gained no benefit from the implant, all of the remaining patients have been able to achieve significant tidal volumes with the DPS System. Based on the current results, the NeuRx RA/4 DPS System has demonstrated safety and efficacy in patients with high-level spinal cord injury.
Given the results to date the study has demonstrated preliminary efficacy in this patient population. With no unexpected significant adverse events reported the NeuRx RA/4 DPS System has performed reliably and safely in this patient population.
Device Description: The NeuRx RA/4 Respiratory System is manufactured by Synapse Biomedical. The NeuRx RA/4 System comprises the following components: an external, battery powered Stimulator Device, an associated Programmer/Controller, Intramuscular Electrodes, associated percutaneous Lead Wires, a Surgical Placement Tool Set, and a surgical Mapping Station.
Inclusion Criteria:
- Age 18 years or older
- Cervical spinal cord injury dependent on mechanical ventilation
- Clinically stable following acute spinal cord injury
- Bilateral phrenic nerve function clinically acceptable as demonstrated with EMG recordings and nerve conduction times
- Diaphragm movement with stimulation visible under fluoroscopy
- Clinically acceptable oxygenation on room air (>90%)
- Hemodynamically stable
- No medical co-morbidities that would interfere with the proper placement or function of the device
- Committed primary caregiver
- Negative pregnancy test in females of child-bearing potential
- Informed consent from patient or designated representative
Exclusion Criteria:
- Co-morbid medical conditions that preclude surgery
- Active lung disease (obstructive, restrictive or membrane diseases)
- Active cardiovascular disease
- Active brain disease
- Hemodynamic instability or low oxygen levels on room air
- Hospitalization for or a treated active infection within the last 3 months
- Significant scoliosis or chest deformity
- Marked obesity
- Anticipated poor compliance with protocol by either patient or primary caregiver.
- Currently breastfeeding
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeuRx DPS | Experimental | Device: NeuRx DPSLaparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older
- Cervical spinal cord injury dependent on mechanical ventilation
- Clinically stable following acute spinal cord injury
- Bilateral phrenic nerve function clinically acceptable as demonstrated with EMG recordings and nerve conduction times
- Diaphragm movement with stimulation visible under fluoroscopy
Key exclusion criteria (10 listed)
- Co-morbid medical conditions that preclude surgery
- Active lung disease (obstructive, restrictive or membrane diseases)
- Active cardiovascular disease
- Active brain disease
- Hemodynamic instability or low oxygen levels on room air
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuRx DPSLaparoscopic implantation of diaphragm electrodes and subsequent pacing with the NeuRx DPS. | Device | NeuRx DPS |
Primary outcome
Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period.
Time frame: Within one year after implantation
Number of enrolled subjects that successfully maintained clinically acceptable tidal volumes greater than basal requirements over a continuous 4 hour period.
2 secondary outcomes
Achieve Clinically Acceptable Basal Metabolic Requirement of Tidal Volume Measured in ml During Chronic Stimulation.
Time frame: Within one year after implantation
Number of Patients That Use NeuRx DPS to Breathe Without the Assistance of a Mechanical Ventilator for 24 Continuous Hours a Day
Time frame: Within one year of implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Onders, MD principal investigator
University Hospitals Cleveland Medical Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuRx DPS in people with Spinal Cord Injury and Quadriplegia, run by Synapse Biomedical at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period. (time frame: Within one year after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.