Development of an Implantable Trigeminal Nerve Stimulation System for Drug Resist

DESCRIPTIONprovided by applicantEpilepsy affects three million Americans and fifty million people worldwideDrug resistant epilepsyDREaffects over one third of all people with epilepsyand may lead to unemploymentinjuryand deathTrigeminal Nerve StimulationTNSis an emerging neuromodulation therapy for DREwhich has unique advantages over other techniquesTNS can be delivered bilaterallyat high frequenciesand externally or subcutaneously with excellent safety and efficacyUnique to TNS is the ability to identify responders with external TNSeTNSprior to implantation with a permanent subcutaneous systemsTNSWe have recently completed the first ever randomized control trialRCTof external TNSeTNSandquotinsubjects with DREForty percentpercentexperienced greater thanpercent reduction in seizure frequency atweekswith significant improvements in moodBeck Depression InventoryThis human clinical trial provides strong evidence for proof of concept of TNS in DREThe purpose of this SBIR translational research project is to develop an implantable subcutaneous Trigeminal Nerve Stimulation SystemsTNSTMfor the treatment of DREThis project builds upon NeuroSigmaandapos s experience in external Trigeminal Nerve SystemeTNSTMfor which it was awarded an STTR inThis SBIR brings together a unique team of biomedical engineersneuroscientists and neurosurgeons with seminal experience in the development of Trigeminal Nerve StimulationFurthermorewe plan to collaborate with Stellar Technologiesa leading manufacturer of intracranial electrodesand CCCa respected manufacturer of implantable pulse generators and components sincewho has agreed to modify an existing multichannel IPG which meets NeuroSigmaandapos s unique design specifications for sTNS Epilepsy is a common disorderand many people with epilepsy have poorly controlled seizureswhich do not respond to multiple medications and treatmentThis project is designed to develop a new treatment for epilepsy called Trigeminal Nerve StimulationTrigeminal Nerve Stimulation is a promising new treatment for epilepsybecause it is minimally invasivelow cost and has the ability to significantly reduce seizures andimprove mood