Y P O C T O N Setting up aTMS Clinic O D Daniel Press, M.D. - PowerPoint PPT Presentation

Y P O C T O N Setting up aTMS Clinic O D Daniel Press, M.D. E Associate Professor in Neurology, S Harvard Medical School and A Beth Israel Deaconess Medical Center E L P

Y P O Contents C T O • Safety and training of personnel Starting program N • Equipment • Certification O • Evaluation and Consent D • Treatment Protocol Managing patients E • Assessment S • Maintenance A E • Cost/Billing Long term plans L • Future Developments P

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Y P O Personnel C T O • Clinicians (Neurology / Psychiatry) N • Administrative support – Scheduling O – Providing information to prospective patients D – Data collection E • Technicians S – TMS trained A – Basic Life Support E – Patient interaction L P

Y P O Safety C T O • Patient selection- seizure risk N • TMS protocol- 10-20hz vs. 1hz O • Safety equipment D – In hospital E – Clinic/outpatient setting S A • Training of staff in management of E seizures L P

Y P O Equipment C T O • TMS machine N – Approved device options – Cooled coil O – We use both neuronetics and magstim D • Earplugs and swimming caps E • Safety equipment S – Tylenol A – To treat a seizure E – Emergency medical services L P

Y P O Neurostar TMS Therapy C System T O Treatment Coil N O Display D Senstar TM E Treatment Link • Contact sensing S • Dose confirmation • Surface field cancellation Mobile Console A • Hygiene barrier E L P

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Y P O TMS Timeline C T 1984 1987 1996 2007 2008 2012 2013-4 O FDA clearance NHIC N Coverage from Medicare Most insurers, Approval Brainsway O (MA,NH,VT Clearance and RI) D Pascual-Leone, et. al. Cadwell George, et. al. Repetitive TMS E rTMS for depression (rTMS) S Anthony Barker Single Pulse TMS A Neuronetics Phase III E trial of rTMS for Medication-resistant L depression P

Y P O Devices and Financial Models C T O N O D E S Manuf. Neuronetics Brainsway Magstim Magventure Nextstim A FDA Yes Yes Yes yes yes E cleared for depression: L Purchase Mixed Rental Purchase Purchase Mixed P (Purchase + model (purchase + starstim) tracker)

Y P O Initial Evaluation C T O • Referral from treating psychiatrist N • Neurology O – Contraindications D – Effect of medication on TMS • Psychiatry E S – Caution if: Psychotic depression, bipolar, personality disorders A E – At least one adequate trial of antidepressant L medication P

Y P How we saw it… O C T O N O D E S A E L P

Y P How Lean Saw it… O C T O N O D E S A E L P

Y P O Consent C T O • Local ethical/safety committee (not IRB!) N • Discussion of on-label vs. off-label treatment O • Explanation of side-effects D – Seizure – Headache E S – Tinnitus/hearing loss A E L P

Y P O BIDMC Treatment Protocol C T Site Hemisphere Frequency Duration Wait time Repetitions O Neuronetics Left DLPFC 10 Hz 4 seconds 26 75 N (120% MT) seconds (3000 pulses) O DLPFC Right 1 Hz 1600 N/A 1 (110% MT) seconds (1600 pulses) D Brainsway Left DLPFC 18 Hz 2 seconds 20 55 E (120% MT) seconds (1980 pulses) S DLPFC Left DLPFC 20 Hz 2 seconds 28 40 A (5.5 cm) (110% MT) seconds (1600 pulses) E L P

Y P O Initiation Phase C T O • Treatments daily (excluding weekends) N • Mood assessed weekly O • Minimum 2 weeks D • Maximum 6 weeks E • Taper? S A E L P

Y P O Alternatives being investigated C T O • Choosing protocol on clinical N parameters (anxiety, risk of mania/sz) O • Using MRI guidance for targeting D • Using anatomical MRI to help with E intensity of stimulation (particularly in S elderly) A E • Others: mood induction, more than one L session/day P

Y P O Assessment tools C T O • Beck, Hamilton, Visual-analogue scale N • Target symptoms • Clinician evaluation of patient O • Other sources of information (e.g. family, D referring psychiatrist) E • Side effects questionnaire S A • Weekly meeting of all staff to discuss E progress L P

Y P Overall Results from Clinical Program O 50 C 45 BDI score (mean +/- SD) T 40 O 35 N 30 O 25 D 20 E 15 S 10 A 5 N=170 n=165 n=146 n=123 n=71 E 0 L 1 Baseline Week 1 Week 2 Week 3 Week 4 P Time

Y P O Maintenance Phase C T O • Minimal evidence (absence of evidence, not N evidence of absence) • Relapse prevention O D – Start with weekly treatment E – Gradually space out sessions S • “ Watchful Waiting ” /reinduction A – Patient presents when feeling worse E L • “Continuation” vs. “Maintenance” P

Y P O C Maintenance: T Initial Course Maint 1 week Q 2 weeks Q 3-4 weeks O N Reinduction: O D Initial Course Taper 2 to 1x/wk Stop if relapse 2-3/wk Taper E S A E L P

Y P O Cost C T O • Medicare coverage across USA N • Insurance Coverage O • $400-$500 initial session with MT, then D $350-$400 non-MT session E • How frequently to measure MT? S A • Helping with reimbursement, creating E fund for low income patients L P

Y P O Reimbursement for TMS C T O • Currently its approved by most payers N (Medicare, BC/BS, Tufts) O • Each carrier has slightly different criteria D • New devices are coming on line E S A E L P

Percent Improvement (NIBS – Sham) 0 10 20 30 40 50 60 P L E A S E D O N O T C O P Y

Y P Model for therapy O C T O N Expertise in Expertise in Expertise in Expertise in brain brain O the disorder the disorder stimulation stimulation D Clinician-based approach Team-based approach E S A Clinical Standards Committee of Clinical TMS Society E L P

Y P O Future Developments C T O • Targeting (use of structural MRI’s and N fMRI’s for intensity and targeting?) O • Interaction of rTMS with medications D • Predictors of response E • Monitoring response biologically S A • Other indications (pain, seizures, stroke E recovery, Parkinson’s disease) L P

Y P O Questions? C T O N O D E S A E L P