Electrical Activation of The Diaphragm for Ventilatory Assist

NCT00010374 | Completed Results

• 1 other identifier: CLIN 20-0000-0009
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 5

Brief 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. 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.

Conditions

Spinal Cord Injury; Quadriplegia

Keywords

Diaphragm for Ventilatory Assist; environmental/toxic disorders; neurologic and psychiatric disorders; rare disease; spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Within one year after implantation

Secondary Outcomes (2)

• Achieve Clinically Acceptable Basal Metabolic Requirement of Tidal Volume Measured in ml During Chronic Stimulation.

  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

  Within one year of implantation

Study Arms (1)

NeuRx DPS

EXPERIMENTAL

Laparoscopic implantation of 4 NeuRx DPS electrodes and subsequent pacing using the DPS system.

Device: NeuRx DPS

Interventions

NeuRx DPS DEVICE

Laparoscopic implantation of diaphragm electrodes and subsequent pacing with the NeuRx DPS.

NeuRx DPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Synapse Biomedical: lead
• University Hospitals Cleveland Medical Center: collaborator
• Shepherd Center, Atlanta GA: collaborator

Study Sites (5)

Craig Hospital

Englewood, Colorado, 80113-2811, United States

Location

Shepherd Center

Atlanta, Georgia, 30309-1465, United States

Location

University Hospital Of Cleveland

Cleveland, Ohio, 44106, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Vancouver CoastHealth

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Neurologic Manifestations; Mental Disorders; Rare Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Anthony Ignagni
• Organization: Synapse Biomedical, Inc.

aignagni@synapsebiomedical.com

440-774-2488

Study Officials

• Raymond Onders, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: February 2, 2001
• Study Start: February 1, 2000
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 18, 2020
• Results First Posted: July 15, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4)