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Deep Brain Stimulation: Moving toward a Clinically Efficient and Available Therapy

Deep Brain Stimulation: Moving toward a Clinically Efficient and Available Therapy. Peter Konrad, MD PhD Director, Functional Neurosurgery Vanderbilt University. Disclosures. I will be discussing off-label use of DBS devices and technology and will indicate when this is the case

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Deep Brain Stimulation: Moving toward a Clinically Efficient and Available Therapy

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  1. Deep Brain Stimulation: Moving toward a Clinically Efficient and Available Therapy Peter Konrad, MD PhD Director, Functional Neurosurgery Vanderbilt University

  2. Disclosures • I will be discussing off-label use of DBS devices and technology and will indicate when this is the case • Consulting: Medtronic Neurological, FHC Inc. • Research support: NIH, DoD, Medtronic Neurological • Financial interest: • CMO, Fiduciary: Neurotargeting • CMO: GSCII

  3. Therapy that works • Evidence for its effectiveness • Class I data (PD primarily) • Number of papers • Symptomatic benefit • Diseases that are presently approved • Parkinson’s (1,000,000) • Essential Tremor (5,000,000) • Dystonia (Humanitarian Use) • OCD (Humanitarian Use) VU Regional Population: 22.8 Million * US data per National Parkinson’s Found, NINDS, Movement Disorders Society - 2004

  4. Potential for Future • PAIN (Neuropathic) • Depression • Epilepsy • Obesity • Substance abuse • Cluster Headaches • ANY focal circuitry pathology • Cingulum – Depression • Ant Capsule - OCD • Vim – Tremor • Vc - Pain • GPi – Dystonia, rigidity • STN – Dyskinesia, tremor, DA effects • PVG / PAG – Pain

  5. Total Implanted DBS Patients MRI (Asleep) Probabilistic atlas MER +/- < 4 hours Frameless; Commercial MER, Bilateral; Lead – 3D – IPG < 6-8 hours OCD (HUD) Universal frames, MER, Unilateral; Lead-IPG 8+ hours DYSTONIA (HUD) PD TREMOR Courtesy Medtronic Neurological

  6. Vanderbilt Experience 2ndFuncNsgn Konrad Frameless Neimat

  7. Affiliated Movement Specialists Regional Population: 22.8 Million Steps towards clinical efficiency: Patient selection (Case Conference) • Parkinson’s disease: • Psychological co-morbidities: Gpi vs STN • DA effects: STN • Tremor alone vs other symptoms: Vim vs STN • Essential tremor: • Vim: unilateral / bilateral implant • Dystonia: • Gpi vs STN • Cervical dystonia • DYT1 • Generalized

  8. Steps towards clinical efficiency: OR Efficiency • DBS lead implantation • OR time reduction (institutional cost / physician time) • Imaging needs (CT versus MRI versus both) • Radiology department time (MRI Guided implants) • ICU versus ward admission • IPG implantation (physician / institutional revenue) • OR time • Single versus dual IPG • Rechargeable IPG (inadequate payment)

  9. Steps towards clinical efficiency: Programming • One hour per DBS lead: initial visit • Several follow up visits: 30 min • Need for telemetry based follow up • Patient diaries (motor, QoL indexes) between visits needed to quantify effect of therapy • Smart Guided programming • Remote patient adjustment • Quantify DBS impact on daily activity • Sensor development • Drug / activity diary • QoL assessments • Reduce time to measure and effect change

  10. Steps towards greater availability: Referralflow • Who is the prescriber of the therapy? • Community Neurologist • Psychiatrist? Anesthesiologist? Neurosciences center? • Why would they continue to refer patients? • Belief in therapy • Marketing advantage among competing groups • Desire for comprehensive expertise • How to create Smart referrals? • Educate on patient selection • How to reduce unhappy end-users • Improve implant management in the hands of programmer • Make it easier, document effective and ineffective management strategies • Reduce return rates to surgical centers for therapy re-assessments

  11. Steps towards greater availability: Technology Leaps • NANS I3: Forum to discuss device platform / industry needs • FDA: Time to reach transformative technology release – decades • Failure to demonstrate RCT evidence • Enrollment need? • Does RCT generate best data for device efficacy and safety? • Statistical n: useful if large, normal distribution not realistic with device categories? • Are devices necessarily coupled with disease? Should FDA label every approved device for a specific disease (thereby requiring every new application for disease to be retested for approved sales in the US? • New Platforms needed for technology to grow. • Wireless technology • Body-wide Power supply for devices • Biologic Interface for smaller electrodes / neural interface

  12. 2020? New patient Atlas • Evidence based targeting • OR time < 2 hours • Intraoperative neurophysiology +/- • > 30% cases done under anesthesia • Multiple leads / contacts with field shaping • Smarter programming: less time, more customized therapy Rigid + Non-Rigid Registration

  13. Summary • DBS is a beneficial technology: Parkinson’s disease, essential tremor, dystonia, OCD • Market growth now attracts more than one company • Prescribers (neurologists): becoming comfortable with technology – but poor penetration • Implanting centers: sophistication emerging that improves efficiency and safety profile • Future: • Reduced discomfort for procedure (awake vs asleep) • More robust tolerance for lead placement • Wider range of applications believed

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