Subdural Pharmacotherapy Device (SPD) For epilepsy treatment. Ruben Kuzniecky, MD NYU Epilepsy Center
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1 Subdural Pharmacotherapy Device (SPD) For epilepsy treatment Ruben Kuzniecky, MD NYU Epilepsy Center
2 May 31, 1942
3 Current Approach Selective Therapy Why drug delivery to CNS? F 16 USAF GBU 28
4 Why drug delivery to CNS? Many patients with refractory epilepsy are not candidates for surgery, and are not helped by AEDs It is estimated that about 200,000 patients in the U.S. are not candidates for currently available epilepsy surgery. There is still a large unmet need Because it seems to work!!!!!!!
5 From: Ludvig et al., Epilepsia 2006
6 Epidurally delivered pentobarbital can terminate focal neocortical seizures in rats 226 mm of PB
7 Suppression of focal neocortical EEG spiking in the seizure focus, in epilepsy patients (From: Madhavan, Kuzniecky et al., 2008, Epilepsy Research)
8 Design of the first generation SPD, a hybrid neuroprosthesis, for the treatment of focal neocortical epilepsy affecting ~ 150,000 people in US (based on US Patent #6,497,699 to Ludvig and Kovacs in 2002)
9 Device hardware & software (We consider the SPD developed if: it is fully implantable, it properly executes all minipump functions, it effectively transmits/receives data and instructions, it can be powered by a single battery for at least 4 years)
10 SPD hardware Subdural strip Dual minipump Microcontroller, side 1 Microcontroller, side 2 (From: Medveczky et al., in preparation for J. Neurosci. Meth.)
11
12 Frontal cortical subdural EEG recordings transmitted by the SPD RF module Ipsilateral Contralateral 420 V sec Anesthesia during surgery Quiet wakefulness in home cage Chewing artifacts Moving around during memory task Eating during memory task Ketamine sedation for minipump refilling Effect of subdural (ipsilat.) Ach delivery
13 Antiepileptic efficacy it is able to completely prevent the occurrence of focal neocortical seizures, and it can maintain this efficacy for long periods without the induction of tolerance)
14 Basic properties of the muscimol solution delivered with the SPD Amanita Muscaria GABA A agonist
15 Termination of Ach induced frontal cortical EEG seizures by 1.0 mm muscimol delivered via the SPD in a bonnet macaque
16 Long term periodic muscimol delivery into the primate frontal cortex via the SPD prevents focal seizures
17 3 H muscimol autoradiography with thionin counterstaining: coronal section from the brain of a rat subjected to epidural 3 H muscimol exposure for 1 hour (Histology/autoradiography made at NeuroScience Associates, by Dr. Robert Switzer)
18 Device safety SPD safety can be quantified if its long term use is not accompanied with: neurological symptoms cognitive, emotional and motivational impairment abnormal neocortical EEG and cell firing patterns systemic side effects infection)
19 Monkey behavioral testing apparatus, suitable for assessing motor, cognitive and motivational functions
20 Acquisition of spatial memory tasks by macaque monkeys before SPD implantation (Test described in: Ludvig et al., 2003; Behav. Brain Res.)
21 Acquisition of a new spatial memory task by macaque monkeys during long term (12 h interval) muscimol delivery with the SPD
22 EEG effects of subdural Ach and muscimol applications with the SPD; local and systemic concentrations of the applied muscimol (HPLC assay made at Stanford Research Institute by Dr. Jacqueline Vazquez DeRose)
23 Conclusions In its present state, the muscimol delivering SPD implant can prevent focal neocortical seizures in primates for many months without apparent side effects or tolerance. Animals tolerate the device and drug without major problems. Many Challenges remain ahead: Engineering Safety in humans
24 What is this?
25 Key team members in 2011 Neuroscience studies : Nandor Ludvig, M.D., Ph.D. (Program Director ) Hai M. Tang, M.D. (animal experiments) Shirn L. Baptiste, B.S. (animal experiments) Carol Novotney, D.V.M. (veterinary consultation at SUNY) Jacqueline Vazquez DeRose, Ph.D. ( HPLC at Stanford Res. Inst.) Robert Switzer, Ph.D. (autoradiography at NeuroScience Assoc.) Engineering studies: Clinical studies: Neurosurgery studies: Industrial partners: Geza Medveczky, M.S. (hardware and software at NYU) H. Jonathan Chao, Ph.D. (hardware at NYU Poly) N. Sertac Artan, Ph.D. (hardware and software at NYU Poly) Sandor Toth, M.S. (hardware and software) Ruben I. Kuzniecky, M.D. (epileptology) Orrin Devinsky, M.D. (epileptology) Jacqueline A. French, M.D. (epileptology) Chad Carlson, M.D. (epileptology) Werner K. Doyle, M.D. (implantation) John G. Kral, M.D., Ph.D., (general surgery consultation at SUNY) Cygnus (control unit manufacturing) DocXS Biomedical (subdural strip manufacturing)
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