Let me just kind of show you a little bit, you know, and this is just really the device units is very just like a hand-sized, small units, powered by a nine-volt battery. It’s portable, it’s easy to use, I can just clip on my belt and I can, you know, do the therapy at the same time. So it does have a lot of advantages. And even you can do it at home for certain disease conditions...
Let me just kind of show you a little bit, you know, and this is just really the device units is very just like a hand-sized, small units, powered by a nine-volt battery. It’s portable, it’s easy to use, I can just clip on my belt and I can, you know, do the therapy at the same time. So it does have a lot of advantages. And even you can do it at home for certain disease conditions. The TRANSPORT-2 study is funded by the National Institute of Health back in 2018. At that time, there’s quite a bit of small single-center proof of concept study, all showing the transcranial direct current stimulation showed very good promise to help with the stroke patient to improve their motor function. At that time, most of the study with the cap of their dose at 2 milliamps, the results are kind of variable, inconsistent. And then my lab and also Dr Gaffrey Schrock from Boston, and we did several studies where it shows doubling the dose to the full milliamp, it’s safe, it’s tolerable for stroke patients. And at that time also a lot of concern, maybe the four milliamp may not be tolerable for patients or healthy controls. And also, there’s data suggesting using the high dose seems more effective to increase or inhibit the cortical excitability and depends on the modality of the device. So we saw that would be great and we can do a big study and so we can see which group is doing better. You know, our hypothesis at that time is where the four milliamp is better than you know and the two milliamp and better than the sham and the stimulations. The sham stimulation only receive 30 seconds just give a little perception so the patient doesn’t really know which group of their they are in. Interestingly we actually did a survey at the end of this asking them to make a guess and also asking the person who provided the therapy to also make a guess in the end they really don’t know which group they’re in. Of course you can’t just stimulate the brain and you also have to do the test-based therapy and together you know to let the brain to rewire so that’s what I’m showing is we’re doing called constraint-induced movement therapy which proved to be effective and you know about 20 years ago. The concept is really you know as you know I’m a stroke victim my right hand is affected the side my left hand is good but now I have to force to use this one but how I can force this I basically to constrain with my good hand with a big glove, so again I say I can’t use my left hand I have to constantly use my right hand. At the same time I’m doing the anodal stimulation to boost you know cortical excitability on the side I have a stroke. The contralateral side believe it or not after stroke actually over-activated I magic protocol a cathodal stimulation here to inhibit and a peripheral and I wear the gloves, I can’t use my good hand. So every day I can force to use my affected hand. So stimulation was 30 minutes. And the whole rehab therapy is a two-hour active time. Means you go to the bathroom, you have to make up the time. This is almost the five times of the therapy most stroke survivors receive it from their rehab. You know, from rehab session. because typically a session is 45 minutes. The act time they receive is just about 20, 25 minutes, but we actually have to do 120 minutes active time. And we do five sessions per week and for two weeks, so total is 10 sessions. And then we look at the outcome immediately after 10 sessions for day 15, day 45, which is 30 days, and day 105, which is 90 days after the intervention, so we can assess for a shorter-term and a long-term outcome. But the results, there are some part that really came out as we expected, but some results come out as unexpected. The part I expected is the proposed intervention was safe, tolerable, and it’s feasible. We really only have two patients withdraw from the study, despite all the challenges from the COVID. Part of the surprise to us is we initially made a hypothesis that the formula will be better. At the same time, we’re safe and tolerable. But what we find out is three groups, they all improve. There’s no separation at a day 15, which is our primary endpoint. even on day 45 and day 105, there’s no… and they continue to improve, but there’s just no separation among the three groups. So I have to say a little bit disappointing, but that’s based on predefined study, and we hope to do a further analysis to see if we can… and we can dig a little bit more. At this moment, because it is a neutral study, we can’t recommend it to stroke patients to use the transcranial direct current stimulation. But I would say, we do confirm the CIMT, Constraint-Induced Movement Therapy, the rehab therapy, which everybody will see is actually quite an effective, most of the occupational therapy or physical therapy, actually, and they know how to do this. But it is a very intensive therapy. Not all the clinics that provide therapy. So for stroke survivors, you should talk to your therapist to consider and to receive CIMT therapy. It’s quite effective. We are here to present the data, and there are a lot of other brain stimulation options. This is just called direct current stimulation. There’s alternating current stimulation. There’s a magnetic stimulation, which uses a magnetic field to generate electropores. My lab also talks about ultrasound stimulations. There are other invasive brain stimulation as well. So there’s a lot of options. At the end of the day I believe it’s a technology, patient selection and outcomes, that will make us successful.
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