DEEP BRAIN STIMULATION: MOVING TOWARD A CLINICALLY EFFICIENT AND AVAILABLE THERAPY

Peter Konrad, MD PhDDirector, Functional NeurosurgeryVanderbilt University

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

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)

Prevelance Pts in treatment % Refractory % DBS candidates

PD 0.0036% 82,985 25% (20,746) 70% (14,522)ET 0.01818% 4,149 20% (830) 50% (415)

Dystonia 0.0057% NA 5-50% (3000) ? (300?)

* US data per National Parkinson’s Found, NINDS, Movement Disorders Society - 2004

VU Regional Population: 22.8 Million

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

Total Implanted DBS Patients

Courtesy Medtronic Neurological

TREMOR

Universal frames, MER,Unilateral; Lead-IPG8+ hours

DYSTONIA (HUD)

PD

MRI (Asleep)Probabilistic atlasMER +/-< 4 hours

Frameless; Commercial MER,Bilateral; Lead – 3D – IPG< 6-8 hours

OCD (HUD)

Vanderbilt Experience

1998

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0

20

40

60

80

100

120

DBS Surgeries

ST II

N=758 patients

Marketing; Increase Neurology

VU DBS Program:

2 Functional Nsg

8 MD Neurologists

2 Neuropsychologist

3 Neurophysiologists

1 PT (Belmont)

Frameless

2nd Func Nsgn

Konrad

Neimat

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

Affiliated Movement Specialists

Regional Population: 22.8 Million

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)

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

Steps towards greater availability: Referral flow• 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

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

2020?• 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

Atlas New patient

Rigid + Non-RigidRegistration

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