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Thread: Diaphram Pacers used in SCI patients to be made available to ALS Patients?

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    Senior Member golanbenoni's Avatar
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    Diaphram Pacers used in SCI patients to be made available to ALS Patients?

    On one of the several video interviews in recent days with Dr. Young and a member of CR's medical team -- a reference to a method involving electrodes and their ability to aid patients on respirators -- was this specific to the "diaphram pacers" that CR mentioned in his BBC interview last month?

    Golan.

  2. #2
    Golan,

    There are two types of pacers that are used to help breathing in people. One is to stimulate the phrenic nerves which come out of the spinal cord at C3-4. The other is to place electrodes directly on the diaphragm. The approach taken by Dr. Onders at Case Western Reserve University is to place the electrodes "non-invasively". I did not know until the interviews that the first two patients that Dr. Onders did were unsuccessful. Please note that diaphragm pacers have been used and applied in Europe for many years (since late 1980s) but the electrodes were placed with surgery. I met a woman, for example, in Hong Kong that had high cervical spinal cord injury and she had phrenic nerve stimulation that did not work and then had diaphragm electrodes placed in 1991 that is working extremely well. Most people meeting her for the first time would not know that she cannot breathe on her own. Her voice is strong. I was also surprised to hear that Dr. Onders was using diaphragm pacing for patients with ALS. I find it surprising because people who have respiratory difficulties in ALS have degeneration of the motoneurons. Diaphragm pacing should not work as well. Ventilation will be necessary as the disease progresses. Wise.

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    Senior Member golanbenoni's Avatar
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    Pilot Clinical Trial will Test Diaphragm Stimulation Device

    Date: October 28, 2004
    URL: http://www.alsa.org/news/article.cfm...FTOKEN=1655311
    Source: ALS Association

    Raymond P. Onders, M.D. of the University Hospitals of Cleveland has informed The ALS Association about a new pilot study in ALS for which he is the principal investigator. Dr. Onders and his colleagues report that they are preparing to begin a clinical trial titled, Muscle Stimulation of the Diaphragm in ALS, in a small group of patients with ALS. The purpose of this research study is to find out if an experimental "diaphragm pacing system can provide stimulation to the diaphragm to maintain its strength and potentially help with the breathing problems associated with ALS." Although there have been similar studies with encouraging results in a few people with spinal cord injuries, the diaphragm pacing system has not been tested in people living with ALS.

    The study includes a surgical procedure to place electrodes (flat metal disks) onto the diaphragm. The electrodes will be attached to an electric stimulator device that is outside of the body. General anesthesia is required and the surgical procedure is done through a laparoscope. As with any surgery, and for people with ALS with weakened breathing muscles, there are risks associated with the procedure. Dr. Onders indicates that the study has been approved by the Food and Drug Administration (FDA) and a institutional review board (IRB). "This is an investigational study that we hope with time will lead us to helping patients with ALS be able to breathe better and have an improved quality of life," states Dr. Onders.

    The investigators have applied for grants to help cover the costs of this study, but at present this is an un-sponsored study. It is possible that some of the expenses may be covered by Medicare and Medicaid, and perhaps private insurance. People interested in participating in the study should ask the investigators for a listing of all anticipated out-of-pocket expenses. The ALS Association will keep the ALS community informed about grants for this research project and the status of insurance coverage as more information is known.

    This 12-month study includes nine visits to the University Hospitals of Cleveland and will enroll 10 people with ALS who meet the inclusion criteria. There is an extensive initial assessment and screening process.

    The primary questions this study is designed to answer are:

    1. Are the surgical procedure and electrical stimulation of the phrenic nerve safe in people with ALS?
    2. Is the electrical stimulation tolerable for people with ALS?

    After the surgery, the nine months of the study include having the patient or caregiver gradually increase the power and frequency of the electric stimulator (pacing device) to "train" the diaphragm. Another question the study hopes to gather information about is whether or not the electrical stimulation will help the diaphragm be stronger and more effective for a longer period of time than it would have been without the electric stimulation. In addition, the study will evaluate whether the electric stimulation of the phrenic nerve can cause diaphragm muscle contraction in a manner that will support breathing.

    The study is not designed to slow or stop the progression of ALS, and some patients in the study may develop symptoms of respiratory muscle weakness and trouble breathing. People in the study who need support for breathing such as noninvasive ventilation (BiPap) at some point, should not delay seeking care.

    Q and A:

    Q: Is it unusual for a research study to require that the patients pay out-of-pocket?

    A: Yes, it is unusual to have patients in a research study responsible for the costs of the study. This is a concern for The ALS Association; however, there is the possibility of grant sponsorship the investigators have applied for, and insurance companies may pay for a portion of the study expenses.



    Q: Will the diaphragm pacing device support my breathing so that I will not need to use noninvasive ventilation (BiPap) or long-term mechanical ventilation with a tracheostomy?

    A: At this time, no one knows if the electrical stimulation will support breathing for people with ALS. Although the primary purpose of this study is to evaluate the safety and tolerability of the procedure and the electrical stimulation, the investigators will also evaluate if the device supports breathing and/or strengthens the diaphragm muscle.



    Q: Was the diaphragm pacing device tested in an ALS animal model?

    A: The ALS Association is not aware of any ALS animal model studies using this device and would be very interested is seeing such a study conducted. The questions the research investigators are asking in this study are important and could lead to a major advance in the care of people with ALS. However, there are several yet unanswered points such as how to evaluate outcomes without control groups, and the relative value of the pacing device compared to noninvasive ventilation from cost and quality-of-life perspectives.



    Q: If my breathing tests are normal and I am not having any trouble breathing now, can I enroll in the study to prevent future muscle weakness?

    A: No, for a person who does not have diaphragm muscle weakness, it is not appropriate to undergo the surgery and electric stimulation. To meet the inclusion criteria established by the investigators for this study, people must have evidence of diaphragm weakness within a specific range that has been determined by the study investigators.



    Q: How can I get more information about this study?

    A: Contact Dr. Raymond P. Onders by email at Raymond.Onders@uhhs.com

  4. #4
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    My son was the 5th person to have the get the pacer in cleveland. It works extremely well. He now is free of his ventiltor on his chair. What a difference that makes by reducing the size of his chair by 2 feet. The health benefits are great too. He hasn't had any chest infections since and his need for coughing is greatly reduced. We live in Vancouver Canada and we are going to be sending a surgeon to train with Dr. Onders so that we can begin to offer the pacer here in Canada. We have a high population of ALS and the hope is that it will be benefical to those.
    My other hope is that the pacer will be used on acute injuries that are ventilated initially but eventually come off the ventilator. I have spoken with people who have had to come off the ventilator later and know how difficult it is. With the pacer initally placed in these people it will keep the diaphram strong and make it much easier to resume normal breathing. Not the mention the risks of infection from ventilation will be reduced.
    Dr. Onders and his team are super people, very dedicated to the pacing program. I hope they are successful in getting their funding to expand this technology.

  5. #5
    Senior Member Leo's Avatar
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    Thanks for the update Nancy. Amazing...

    "All you have to decide is what to do with the time that is given you."
    Gandolf the Gray

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    Wise,

    I wanted to clarify a couple of items in your post...

    Our first patient, implanted by Dr. Onders in March 2000, has been successfully using the diaphragm pacing system for over 4 years (24 hours/day - 7 days/week). He did require a revision surgery to place new electrodes in his right diaphragm to achieve sufficient volumes, which was done a few months after his original surgery. Our second patient has been the only patient that has not been able to benefit from the pacing system. Since then, with a change in our inclusion criteria, we have been successful in all of our patients.

    In ALS our clinical study / device is not intended to provide ventilation for patients that have had significant degeneration of the motor neurons, but rather strengthen and improve the fatigue resistance of the stimulatable muscle to improve respiratory function and slow the progression. If this pilot study is able to demonstrate a portion of the conditioning and endurance improvements that we have experienced in the conditioning phase of our spinal cord injury investigation we will potentially have a significant effect on the quality of life and respiratory health of individuals with ALS.

    Tony

    Originally posted by Wise Young:


    There are two types of pacers that are used to help breathing in people. One is to stimulate the phrenic nerves which come out of the spinal cord at C3-4. The other is to place electrodes directly on the diaphragm. The approach taken by Dr. Onders at Case Western Reserve University is to place the electrodes "non-invasively". I did not know until the interviews that the first two patients that Dr. Onders did were unsuccessful. Please note that diaphragm pacers have been used and applied in Europe for many years (since late 1980s) but the electrodes were placed with surgery. I met a woman, for example, in Hong Kong that had high cervical spinal cord injury and she had phrenic nerve stimulation that did not work and then had diaphragm electrodes placed in 1991 that is working extremely well. Most people meeting her for the first time would not know that she cannot breathe on her own. Her voice is strong. I was also surprised to hear that Dr. Onders was using diaphragm pacing for patients with ALS. I find it surprising because people who have respiratory difficulties in ALS have degeneration of the motoneurons. Diaphragm pacing should not work as well. Ventilation will be necessary as the disease progresses. Wise.
    Anthony R. Ignagni
    President & CEO
    Synapse Biomedical, Inc.

  7. #7
    Tony,

    I was to apologize for replying to the question to me with a dearth of data. I was just reflecting my surprise that Dr. Onders had mentioned at an interview on Foxnews that the first two patients before Christopher Reeve was not as successful as I had thought. I am very glad that the firt patient has been on the stimulator of the past four years. Thank you for the correction.

    To other readers of this post, I want to say that I have not been privy to the results of the study and that I only meant to point out that Christopher was courageous and contributed to the study. Because the procedure does not require extensive surgery, it has major advantages over previous approaches.

    Wise.

    [This message was edited by Wise Young on 11-11-04 at 05:35 PM.]

  8. #8
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    Wise,

    I did not mean to come across anywhere near obstreperous. I saw the Fox news interview and it did come across that we weren't successful in our first two patients. I was called shortly there-after by our first patient and asked why we didn't consider him successful when he was using the system full time!

    As Christopher demonstrated with his participation in our study, all of our participants in the clinical study have been courageous individuals. Christopher was a very motivated person and was an excellant participant. Not only was he motivated to achieve what he did, but he was motivational in his example and the encouragement that he provided to us to accelerate and expand into other areas such as ALS. We learn from each and every participant, including NancyR's son who helped us streamline the post surgical conditioning and is a success as she discussed below.

    I look forward to continuing our efforts to investigate the safety and efficacy of these devices in our studies being sponsored by University Hospitals of Cleveland. I appreciate your comments and would welcome any additional input that you may have.

    Sincerely,
    Tony

    Anthony R. Ignagni
    President & CEO
    Synapse Biomedical, Inc.

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