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Thread: Dr. Young: NASCINET Steps for becoming a volunteer?

  1. #21
    Senior Member Norm's Avatar
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    I also want to add doesn't Locomotor training sometimes produce return? Couldn't that skew the results. You may not know which brought back the return the stem cells or the loco.
    "Some people say that, the longer you go the better it gets the more you get used to it, I'm actually finding the opposite is true."

    -Christopher Reeve on his Paralysis

  2. #22
    Quote Originally Posted by Norm View Post
    I also want to add doesn't Locomotor training sometimes produce return? Couldn't that skew the results. You may not know which brought back the return the stem cells or the loco.

    Good point Norm, this was also discussed at the meetings in Austin. Scroll up to post #14.

  3. #23
    Senior Member Leo's Avatar
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    Quote Originally Posted by Norm View Post
    Dr, Young, Well I & I'm sure others can stand with a standing frame, but our bones density is to weak for locomotor training. It taken years to try to get these levels up. It been almost two years & my levels are still not up enough. I started Forteo injections in Dec. for this very reason. So you can count a bunch of us out if locomotor is necessary.

    Norm, my thought to this is first FES bike for muscle mass and bone density

    just a dreamer
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    2010 SCINet Clinical Trial Support Squad Member

    "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

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  4. #24
    Quote Originally Posted by Norm View Post
    I also want to add doesn't Locomotor training sometimes produce return? Couldn't that skew the results. You may not know which brought back the return the stem cells or the loco.
    Let me try to explain why locomotion is one of the outcome measures of our trial.
    • It is an outcome measure for both paras and quads. We are going to have both in our trial.
    • Validated outcome measures are available for walking but not for arm or hand function yet. Few validated outcome measures are available for hand or arm function. Furthermore, hand and arm function vary a great deal depending on the level of injury.
    • Walking is pre-programmed into the spinal cord. Many studies have shown that both quads and paras recover walking if they are incomplete. The Central Pattern Generator (CPG) located in the L2 spinal cord has most of the programs from walking, running, hopping, skipping, etc. You don't need a lot of axons to activate the CPG.
    • Locomotor training has been shown to restore walking in people who have never walked after injury. It is true that this occurs mainly in people who are incomplete. However, if the treatment makes more people incomplete, we expect to see more people walk in the trial.

    I realize that there are other worthwhile goals of spinal cord injury therapy and I support trials of therapies aimed at restoring other functions and our therapy may well restore sensation, hand function, bowel and bladder function, sexual function, etc. However, walking recovery is a worthwhile goal, don't you think?

    Regarding the osteoporosis, it is something that we are very concerned by. However, rather than imposing an arbitrary bone density criterion on who would be able to join the trial, I thought that a better criterion is simply a person who is able to tolerate doing weight bearing for an hour a day. We will of course obtain bone density measurements and I will rely on investigators' judgments concerning whether or not a person is able to engage in overground locomotor exercise.

    Many scientists and clinicians in the field believe that motor recovery will not occur without intensive repetitive exercises. Such exercises have been shown to be important for locomotor recovery in animals. Dozens of studies in the past decade have shown the locomotor training improves both reflexes and muscle strength of people who have never walked after spinal cord injury. However, no study has shown that locomotor training can return independent voluntary locomotion to people who have chronic ASIA A. If a substantial number of subjects who are ASIA A walk as a result of this treatment, I don't think that it can be attributed to the locomotor training.

    Some of our investigators believe that we must include a rehabilitation only group in the trial. Please note that this increases the costs of the trial by nearly a third, to about $33 million compared to $23 million. So, it is not a trivial decision from a monetary point of view. We even discussed the possibility of not including a rehabilitation component to the trial. A number of our investigators felt that this omission would be unethical and that we would be short-changing the therapy by not providing patients an opportunity to do locomotor training. Indeed, some people feel that the absence of training will guarantee no significant motor recovery.

    Wise.
    Last edited by Wise Young; 03-19-2009 at 05:09 PM. Reason: corrected and added words (red)

  5. #25
    Senior Member Norm's Avatar
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    Dr. Young, Thanx for the clairifcation.
    "Some people say that, the longer you go the better it gets the more you get used to it, I'm actually finding the opposite is true."

    -Christopher Reeve on his Paralysis

  6. #26
    Quote Originally Posted by Leo View Post
    Norm, my thought to this is first FES bike for muscle mass and bone density

    just a dreamer
    Leo,

    Thanks. From a common sense point of view, wouldn't the best approach is to start bearing one's own weight. People should consult with their doctors and start out slowly, perhaps five minutes a day and slowly increase to an hour a day. I know many people with spinal cord injury who stand at least an hour a day and believe that most people should be able to achieve this.

    I do understand that meeting this criterion may be difficult for some people who have hip or knee joint problems, who have severe osteoporosis and a history of fractures, who may have contractures that prevent them from standing, and who may have postural hypotension. On the other hand, I hope that people will agree with me that standing one hour a day is a reasonable criterion for joining a clinical trial that will use walking as an outcome. If people cannot stand, they cannot walk.

    The criterion is also meant to stimulate discussion and awareness. Many people may be wishing for a therapy that could convert them to walkers after not walking for many years. In my opinion, this is wishful thinking. People need to prepare for walking. I know that it is possible because I know many people who have been preparing and are able to bear their own weight for at least an hour a day or longer.

    In Austin, many people came to me with requests for expanding the trial inclusion criteria to people who are ASIA B and even ASIA C. I am considering this but believe that we are not testing enough subjects in the U.S. trial to be able to come up with credible data if we include ASIA B and C.

    In China, where we are planning to do about 400 subjects, I am pushing hard to include chronic B and C. We have enough patients to be able to tell a significant effect. In the U.S. trials, however, we won't have enough patients to come up with credible results. Our power analyses suggest that we need at least 60 patients for each treatment+ASIA category group to be able to detect a 10% change in motor or sensory score with a p<0.05.

    Funding is a major issue if we expand the trial. With just 30 subjects per center and 6 centers, we are talking about 180 subjects. At $100,000 per subject, this is $18 million. The cost of the cells alone will be about $6 million. If we include trials for kids and older adults, the total cost comes to about $33 million. This is a lot of money to raise in 12 months time.

    The goal of the trial is to demonstrate safety and efficacy in as short a time and as inexpensively as possible. I believe that we should expand the trial to kids and older people and that this needs to be done earlier rather than later. Likewise, I believe that the trial should be expanded to higher cervical levels but only after our trial shows sufficient benefit to overcome the risk of doing the surgery on people with C4 or higher injuries.

    I know that all this complicated but I hope that the rationale is clear.

    Wise.

  7. #27
    Thanks for the detailed explanation. I'm much too decrepid to meet the criterion and do wish the final outcome measure was different but since walking is comparatively uncomplicated, it makes sense and makes for a solid argument for efficacy. I'm happy that a trial for ASIA A chronics will finally be available soon.

  8. #28
    Quote Originally Posted by antiquity View Post
    Thanks for the detailed explanation. I'm much too decrepid to meet the criterion and do wish the final outcome measure was different but since walking is comparatively uncomplicated, it makes sense and makes for a solid argument for efficacy. I'm happy that a trial for ASIA A chronics will finally be available soon.
    I have been thinking about a study of people with cervical spinal cord injuries, the outcomes, and rehabilitation. For example, a lot of people have biceps (C5), wrist extensors (C6), and even triceps (C7) but lack hand function. I think that we can use the following standardized hand function test (attached).

    Another hand function test is the REL test
    http://www.ifess.org/ifess03/Poster%...%20Popovic.htm

    Wise.
    Last edited by Wise Young; 03-20-2009 at 03:50 AM.

  9. #29
    Quote Originally Posted by Wise Young View Post
    I have been thinking about a study of people with cervical spinal cord injuries, the outcomes, and rehabilitation. For example, a lot of people have biceps (C5), wrist extensors (C6), and even triceps (C7) but lack hand function. I think that we can use the following standardized hand function test (attached).

    Another hand function test is the REL test
    http://www.ifess.org/ifess03/Poster%...%20Popovic.htm

    Wise.
    Sounds good. Because of a lack finger flexion, I couldn't complete any of the REL tasks. Maybe one day.

    Regarding chronic ASIA A's, couldn't severe muscle atrophy give a false negative for recovery, even if they are able to weight bear? If the connections are there but there's no muscle behind it, won't it appear as if regeneration hasn't taken place.

    Could the NIH fund a portion of the trial or is the grant process too lengthy?
    Last edited by antiquity; 03-20-2009 at 12:30 PM.

  10. #30
    Are the people who responded to 4ap better candidates?
    jbs

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