Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia

[Wise Young]

http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00010374?order=12&JServSession Idzone_ct=zhn5b9gan1 (http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00010374?order=12&JServSessionIdzone_ct=zhn5b9gan1)

Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia

This study is currently recruiting patients.

Sponsored by

FDA Office of Orphan Products Development
Case Western Reserve University

Purpose

OBJECTIVES: I. Determine the efficacy and safety of bilateral phrenic nerve pacing via electrodes surgically implanted into the diaphragm to achieve full-time artificial ventilation in patients with ventilator-dependent tetraplegia.

Condition
spinal cord injury


MEDLINEplusÂ*related topics:Â*Â*SpinalÂ*CordÂ*Injuries

Study Type:Â*Treatment


Further Study Details:Â*


PROTOCOL OUTLINE: Patients undergo laparoscopic implantation of intramuscular diaphragm electrodes and initial electrical stimulation. Following a 2-week recovery period, diaphragm pacing is initiated and performed according to a reconditioning program in which the duration and frequency of electrode stimulation is gradually increased.

Patients receive electrode stimulation for 5-10 minutes/hour 8-10 hours/day on week 3, 15-20 minutes/hour 8-10 hours/day on weeks 4 and 5. On weeks 5-15, electrode stimulation time is increased until full-time diaphragm pacing is achieved.

Patients are monitored daily on weeks 7-28 and then followed regularly thereafter.


PROJECTED ACCRUAL: A total of 6 patients (2 patients per year) will be accrued for this study over 3 years.

Eligibility

Ages Eligible for Study:Â* 18 Years Â*and above

Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

High cervical spinal cord transection resulting in tetraplegia Respiratory failure for the past 6 months that requires chronic mechanical ventilatory support Failure of vigorous attempts to wean from ventilatory support

Normal bilateral phrenic nerve function required

--Prior/Concurrent Therapy--

Not specified

--Patient Characteristics--

Age: Adults

Performance status: Stable condition

Hematopoietic: Not specified

Hepatic: Not specified

Renal: Not specified

Cardiovascular: No active cardiovascular disease

Pulmonary: No active lung disease

Other: No active brain disease No significant scoliosis, chest wall deformity, or obesity

Location and Contact Information

Ohio
Case Western Reserve University,Â*Cleveland, Â* Ohio, Â* 44106, Â* United States;Â*Recruiting

Â*Â* Anthony F. DiMarco Â*216-778-2362Â* Â*

Ohio
MetroHealth System,Â*Cleveland, Â* Ohio, Â* 44109, Â* United States;Â*Recruiting

Â*Â* Anthony F. DiMarco Â*216-778-2362Â* Â*

Study chairs or principal investigators

Anthony F. DiMarco,Â* Study Chair
Case Western Reserve University Â*Â*


More Information

More information is available for this study.

Study ID NumbersÂ* 199/15631;Â* CWRU-FDR001839;Â*CWRU-99065-M-99
NLM IdentifierÂ* NCT00010374

Date study startedÂ*February 10, 2000

Last UpdatedÂ* February 1, 2001

[This message was edited by Wise Young on August 06, 2001 at 12:35 PM.]

[Carl R]

what exactly are they trying to achieve in this trial? Is it designed to replicate a cough? Would you not get the same results with a external electrical stimulation (like the QuikCoff)?

[Wise Young]

As I understand it, this is different from the standard phrenic nerve pacing (where the electrodes are just placed around the phrenic nerves). In this case, the electrodes are placed in the muscles of the diaphragm. This ensures better and fuller activation of the diaphragm than just the phrenic nerve stimulation. By the way, this procedure may also work for people who have had damage on their phrenic nucleus and therefore loss of phrenic nerve innervation of one side of the diaphragm (it would maintain the muscles of the diaphragm until the phrenic nerve on the other side can grow to re-innervate both sides). Wise.

[Cynthia]

Do you know if there are any external electrodes or battery pack with this artificial ventilation?

[Wise Young]

Although I have not seen this specific device, I am sure that it must have an external battery pack for power. Nowadays, as you probably know, power can be transferred through the skin via an embedded antenna and therefore there is no need for wires that has to come out of the body for power purposes.

There is an even more exciting advance coming down the pike. I have heard that there are wireless stimulating electrodes being developed. These are tiny electrodes that can be implanted into the muscle and they respond to radiofrequency pulses, converting the energy into electrical current to stimulate the muscles. Such electrodes can be implanted without having to wire them to some kind of controller and therefore would have a much lower risk of infections and allow many more electrodes to be transplanted.

Wise.

[Wise Young]

Updated link to clinicaltrials.gov
http://clinicaltrials.gov/ct/gui/c/a1r/show/NCT00010374?order=5&JServSessionIdzone_ct=nb7y4tvs11