The E-Stand clinical trial is suppose to start today ...

[lunasicc42]

According to their listing on clinicaltrials.gov

It says "study start date: April 28"
How accurate are those start dates on a clinicaltrials.gov listing?

Anyway, is anyone here going or is anyone eligible and interested in contacting them?

https://clinicaltrials.gov/ct2/show/...e-stand&rank=1

[#LHB#]

I was filling out the info and it said "ASIA A-B Motor complete" Then it says you must have full strength in your hands and arms to be included. Do what?

[Silvio GS]

This is the approach that most of us can benefit from now. But, estimated completion date January 2023... It seems that they don't care about making this therapy available as soon as possible, but the opposite, drag it as much as possible

[Sheri]

Now the link says it's not recruiting YET so who knows when it might start. How does this compare to the Pathways one out of Boston that is starting a trial for their first device for spasticity in France and expects to follow up w a second device for function, as well as the California start up where the CEO started crying in the YouTube that we've "waited long enough"?

[mamadavid]

Sheri, could you please give more details about the trials in France?

Now the link says it's not recruiting YET so who knows when it might start. How does this compare to the Pathways one out of Boston that is starting a trial for their first device for spasticity in France and expects to follow up w a second device for function, as well as the California start up where the CEO started crying in the YouTube that we've "waited long enough"?

[Sheri]

I've had a hard time finding solid info re Pathmaker. Thought they'd have something going on in the US since they got some FDA fasttrack thing but all I can find is an announcement that they're starting a trial in France. No details.

http://pmneuro.com/news/press-releases/

[tomsonite]

This is the approach that most of us can benefit from now. But, estimated completion date January 2023... It seems that they don't care about making this therapy available as soon as possible, but the opposite, drag it as much as possible

Based on the completion date, you think that the researchers don't care about making this therapy available to people? Do you judge everyone before you know them?

This is a surgical procedure that involves months of preparation followed by months of training afterwards for every participant. Simply getting enough eligible participants for a procedure like this will be a challenge. If they want to make their study meaningful, they need to get as many subjects as possible. Then there is the time it takes to analyze the mountains of data they collect, and make meaningful conclusions out of it. Lastly, if this stands any chance of becoming a standard treatment, the researchers have to write up their report and then get it published, which can also take over a year, which is a time line that is completely out of the hands of the researchers.

I empathize with your frustration seeing that the completion date for the study is so far away. This does not mean that the researchers don't care about getting the treatment to patients quickly, and it does not mean that other progress won't be made in other labs during that time. Its better of them to give a realistic timeline than to let people develop false hope.

[niallel]

Based on the completion date, you think that the researchers don't care about making this therapy available to people? Do you judge everyone before you know them?

This is a surgical procedure that involves months of preparation followed by months of training afterwards for every participant. Simply getting enough eligible participants for a procedure like this will be a challenge. If they want to make their study meaningful, they need to get as many subjects as possible. Then there is the time it takes to analyze the mountains of data they collect, and make meaningful conclusions out of it. Lastly, if this stands any chance of becoming a standard treatment, the researchers have to write up their report and then get it published, which can also take over a year, which is a time line that is completely out of the hands of the researchers.

I empathize with your frustration seeing that the completion date for the study is so far away. This does not mean that the researchers don't care about getting the treatment to patients quickly, and it does not mean that other progress won't be made in other labs during that time. Its better of them to give a realistic timeline than to let people develop false hope.

I understand what you are saying, I'm thinking you are commenting on a new device or procedure. From what I read into this, its not a new device or procedure its just that they plan on working out what the best parameters are. The device they are planning on using is already an existing regulated device.

"Studies a U.S. FDA-regulated Device Product:

Yes"

Ignoring their trial which isn't going to deliver a new product, just the recommended settings, Silvio is right, this is a device that most of us can benefit from now.

[tomsonite]

I understand what you are saying, I'm thinking you are commenting on a new device or procedure. From what I read into this, its not a new device or procedure its just that they plan on working out what the best parameters are. The device they are planning on using is already an existing regulated device.

"Studies a U.S. FDA-regulated Device Product:

Yes"

Ignoring their trial which isn't going to deliver a new product, just the recommended settings, Silvio is right, this is a device that most of us can benefit from now.

What I am saying is that you can't infer that researchers "don't care about making this therapy available as soon as possible" just because the completion date is far off. That's an incredibly unfair insinuation.

It is not a new device or surgical procedure, per se - the device is currently FDA approved and regulated for neuropathic pain.

They are investigating if they can use this device differently, for a different purpose than what it was originally approved for (enhancing movement after SCI), hence the need for more studies and clinical trials.

I agree that many people with SCI could benefit from it now. That doesn't change our laws, though. This new way of using this device must go through all processes necessary to become FDA approved and regulated, and thus have any chance of being covered by medical insurance. The will of the researchers won't change that.

[niallel]

I agree its unfair to say they don't care.

But bringing the solution to market as soon as possible is something that this trial is not aimed at.