QuadriplegiaNCT00004415
Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients
A study testing Medlink spinal cord electrode in people with Quadriplegia, run by Case Western Reserve University.
Trial summary
OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone. II. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Quadriplegia
- What is being tested?
- Medlink spinal cord electrode
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- May 1991to Sep 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 49 years
- All sexes
- No healthy volunteers
- Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Ventilator dependent quadriplegics who are not candidates for phrenic nerve pacing alone
Must have bilateral partial or unilateral phrenic nerve function
Must have been on ventilator support for at least 6 months and unweanable
--Patient Characteristics--
Cardiovascular: No active cardiovascular disease
Pulmonary: No active lung disease
Other: No active brain disease Stable condition
About this study
OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone.
II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients.
Read the detailed description
PROTOCOL OUTLINE: Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall.
If substantial inspired volumes can be generated by intercostal pacing, a phrenic nerve cuff electrode and radiofrequency receiver are implanted, and patients undergo combined intercostal muscle and diaphragm pacing.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Quadriplegia
- Being tested
- Medlink spinal cord electrode
- Keywords
- environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury
- Medical subject headings
- Quadriplegia, Neurologic Manifestations, Mental Disorders, Rare Diseases, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medlink spinal cord electrodeDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMay 1991
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QuadriplegiaStudies 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
- Enrolment
- 5 participants
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Investigators
- Anthony F. DiMarco, Study chair, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004415
- Sponsor's protocol ID
- 199/13307
- Other IDs
- CWRU-09169-M-91, CWRU-FDR000403
- Status last verified
- Sep 2002
- First submitted
- 18 Oct 1999
- Last updated
- 7 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients
- ClinicalTrials.gov ID
- NCT00004415
- Acronym / sponsor ID
- 199/13307
- Conditions
- Quadriplegia
- Keywords
- environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- May 1991
- Study completion
- Sep 2000
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone.
II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients.
Detailed description
PROTOCOL OUTLINE: Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall.
If substantial inspired volumes can be generated by intercostal pacing, a phrenic nerve cuff electrode and radiofrequency receiver are implanted, and patients undergo combined intercostal muscle and diaphragm pacing.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Medlink spinal cord electrode | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
Anthony F. DiMarco study chair
Case Western Reserve University
Questions about this trial
What is this clinical trial studying?
A study testing Medlink spinal cord electrode in people with Quadriplegia, run by Case Western Reserve University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early. Results are not available in the source record.
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.
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 7 Apr 2015.