Stimulation of Diaphragm Muscle in ALS

[MtPockets]

This is information about a trial program to insert electrodes into the diaphragm to help with breathing. You can read the details at:
http://mda.org/research/view_ctrial.aspx?id=182

Synapse Biomedical, in conjunction with Case Western Reserve University and University Hospitals of Cleveland, have evaluated activating the diaphragm with percutaneous (through the skin) intramuscular electrodes.
The NeuRx-RA/4 DPS System provides an electrical signal to the motor point of the muscle that causes the diaphragm to contract and allows patients to breathe more naturally.

The NeuRx RA/4 DPS System has been implanted in over 10 individuals with ALS, in a pilot study at the University Hospitals of Cleveland that began January 2005.

Given patient results to date (see Stimulation of Diaphragm Muscle in ALS (http://www.mda.org/research/view_ctrial.aspx?id=128)), the data support safety and efficacy to proceed to a pivotal study in this patient population. With no unexpected significant adverse events reported, the NeuRx RA/4 DPS System has performed reliably and safely.



God Bless
Capt AL

[CindyM]

Thanks Captain AL. It is about time they came up with something like this! cindy

[MtPockets]

I received some more information about this study if anyone is interested:
God Bless
Capt AL

Subject: RE: More info on clinical trials Message:

Hello Mr. Marble:
Thank you for your recent inquiry into the clinical trial for Diaphragm Pacing in patients who have ALS. To be eligible for this trial, patients must have a confirmed diagnosis of ALS by the El-Escorial scale. The pulmonary test measuring Forced Vital Capacity (FVC) must be a minimum of 50% at the day of screening and below 85%. This study involves 8 trips to the clinical site. We are located in Cleveland, Ohio. There is a 3 month lead-in in this study. There will be an initial screening and appointments at the 1.5 month and 3 month mark. If all criteria are still met at 3 months, we will proceed with implantation. The implantation is a low risk, minimally invasive out patient procedure.
I have enclosed a copy of our consent form (This is meant for use as reference. The document reviews this year long study in great detail), a document titled screening & demo questions which will help us determine eligibility and contains all the information we need to schedule the screening appointment.

Please contact your Neurologist/Primary Care Physician and have them fax any Pulmonary Function Studies (PFTs), EMGs, radiology tests, lab work, EKG and office notes to 216/983-3069. If you have not had pulmonary testing done recently and wish to come here for the testing/screening day in one visit, we will be glad to schedule you.
If you have any further questions, please feel free to contact either myself or:
Mary Jo Elmo CNP , Project Manager, Diaphragm Pacing Services, University Hospital Case Medical Center, 11100 Euclid Avenue, Cleveland, Ohio 44106
Phone: 216-844-8594 ,Fax: 216-983-3069, e-mail: maryjo.elmo@uhhospitals.org
If I can be of any further assistance, please do not hesitate to contact me.

Thanks,
Jenny

Jennifer Pelcic
Secretary to Dr. Raymond P. Onders
University Hospitals Case Medical Center
11100 Euclid Avenue, LKS 5047
Cleveland, OH 44107
Phone: 216-844-5797, option 2
Fax: 216-983-3069
Email: Jennifer.Pelcic@UHhospitals.org

[stacykoca]

Is anyone familiar with the diaphragm stimulation device? I just read about it in this month MDA/ALS magazine. I would love to hear personal experiences regarding this device.
Thanks so much for your wisdom and hope.
Stacy

[MtPockets]

I have posted an article about it and I am getting additional information about the trials.
Do a search under " Stimulation of Diaphragm Muscle in ALS"
So we do not have multiple Threads about this subject.

God Bless
Capt AL