Because of the link between stroke and VaD, and based on initial results of our stroke treatment, we hypothesize that chronic SPG stimulation may prove beneficial to VaD patients.
Typically, such an hypothesis is tested on animal models prior to human trials. However, in this case no good animal model exists (1). In addition, sufficient safety data about SPG stimulation in humans has been accumulated in BrainsGate's stroke clinical studies. As a result, BrainsGate decided to move directly into clinical studies for VaD.
A large number of patients and long follow-up periods are typically needed in clinical trials for testing treatments for diseases where there is a slow cognitive deterioration. However, SPG stimulation treatment offers a different approach which overcomes these hurdles: a single brain hemisphere can be selectively treated by stimulating the ipsilateral SPG, while maintaining the other hemisphere untreated as control. Treatment effect can then be assessed by comparing the two brain hemispheres for each patient. Using this methodology, each patient serves as his or her own control.
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References: 1. Hainsworth AH and Markus HS, "Do in-vivo experimental models reflect human cerebral small vessel disease? A systematic review", J Cereb Blood Flow Metab 2008 (12):1877-91
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July 15, 2014
ImpACT24 Interim Results
The Data Safety Monitoring Board (the "DSMB") for BrainsGate's study examined the interim results and deterimined the results support the continuation of the study > full story
January 1, 1970
> full story
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