Project: Improving the lives of patients with brain disorders through interactive BRAIN Stimulation (BRAINS)
[Background]_x000D_Healthcare innovations provide great socio-economic benefits to society. Especially in the case of brain diseases, which account for 35% of all burden of diseases in Europe, therapeutic innovation is desperately awaited. Deep brain stimulation (DBS) is a minimally invasive neurosurgical therapy for symptomatic treatment of various neurological disorders. It was approved as a treatment for essential tremor in 1997, for Parkinson's disease (PD) in 2002, and dystonia in 2003. It has since then been used in more than 100,000 patients. DBS can be envisioned as a ‘pacemaker for the brain’; mild electrical stimuli are delivered to brain tissue, via implanted probes, to suppress unwanted activity and restore desired neuronal functions as shown in Figure 1. For PD alone, over 50,000 patients are diagnosed each year in Europe. _x000D__x000D_Recent developments by Sapiens (coordinator of BRAINS) in high-resolution probe design enable patient specific Steering Brain Stimulation (SBS) to reduce stimulation-induced side-effects while COtaining the stimulation intensity levels that are required for obtaining the full therapeutic benefits. The Sapiens SBS implant includes an Implantable Pulse Generator (IPG) in the chest which comprises specific interface electronics to communicate with the small Active Lead Can (ALC) on top of the skull that drives all the electrodes in the high-resolution probe._x000D__x000D_[Goal]_x000D_The goal of BRAINS is to extend the SBS concept to include the capability to locally sense brain activity during the therapy. BRAINS will provide the following unique benefits:_x000D_* For the first time ever, effects of the treatment can be derived directly from the measured brain activity, essential in many (non-motor related) brain disorders_x000D_* The BRAINS integrated solution will be a key enabler in next generation cranial products that can provide enhanced patient comfort, augmented MRI safety, and reduced procedure times._x000D__x000D_[Solution direction]_x000D_Measuring brain signals that are 1.000.000 times smaller than the stimulation voltages can only be realized by integrating the pulse generator with the recording electronics. This is preferably realized closer to the brain than from the IPG, to enhance the recorded signal quality, thereby moving the pulse generation out of the IPG. This effectively means that the functionality of the IPG is reduced to a ‘battery container’ and the ALC is upgraded to an intelligent 2-way interface to the probe. Reducing the functionality of the IPG has another very important advantage as it allows for further miniaturization paving the way for a full cranial solution as is shown in Figure 1 (bottom, right). _x000D__x000D_[Challenge]_x000D_Interleaving recording with stimulation while handling the dynamic range required to avoid saturation of the recording chain by the stimulation artefacts and preserving as much as possible of the non-stationary local-field potential signals constitutes a significant challenge._x000D__x000D_In addition, the battery in the IPG provides – and the cranial electronics requires – a Direct Current (DC) power supply. The required power transfer over an implanted wire in human applications is radically new and challenging from a safety compliance standpoint. Furthermore, it is complicated by the extreme efficiency requirements that are imposed by the lifetime requirements on the primary battery in the IPG. _x000D__x000D_==========================================================================_x000D_Efficient and safe power transfer amongst implanted medical devices is on the cutting edge of today’s technology and is the key for moving DBS to a clinically superior solution for new indications that is tailored and evidence-based. The successful completion of BRAINS truly marks a European world premiere. _x000D_==========================================================================_x000D__x000D_[Consortium]_x000D_The BRAINS Ps together form a well-balanced consortium: high-tech SME P ICsense is uniquely positioned to develop the required advanced ASIC electronics for high-resolution directional brain recording while high-tech SME Sapiens (coordinator of BRAINS) designs the end-to-end system and integrates the BRAINS system. Sapiens will also sponsor the clinical studies (outside the scope of BRAINS) that are necessary to take their BRAINS DBS products to market following the completion of BRAINS. _x000D__x000D_ICsense and Sapiens are leaders in their respective fields and, together with other technical and clinical Ps, already cooperate in the FP7 project “IMPACT” to develop a system that ‘tunes’ the stimulation properties of the high-resolution DBS implant. The high potential return-on-investment of the BRAINS project stems from the large impact that the BRAINS system can make in terms of targeting other indications while improving patient comfort for PD. It leverages the capital intensive implant development that is readily funded independently of BRAINS and for which Sapiens raised €24M+ in venture capital._x000D_
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Acronym
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BRAINS
(Reference Number: 8274)
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Duration
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01/10/2013 - 31/12/2016
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Project Topic
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BRAINS builds on recent advances in Deep Brain Stimulation for Parkinson's Disease through a novel compact design that maximizes patient comfort while minimizing procedure times. BRAINS’ challenging objective is to realize a distributed electronics design to enable the required miniaturization.
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Network
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Eurostars
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Call
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Eurostars Cut-Off 10
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Project partner
