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

Mar 31, 2024 •120 likes •399 views

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

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

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

  3. Y P O C T O N O D E S A E L P

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

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

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

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

  8. Y P O C T O N O D E S A E L P

  9. TMS Timeline Y P O C 1984 1987 1996 2007 2008 2012 2013-4 T FDA O clearance NHIC Coverage from Medicare N 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 A Anthony Barker Single Pulse TMS E L Neuronetics Phase III P trial of rTMS for Medication-resistant depression

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

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

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

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

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

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

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

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

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

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

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

  21. Y P Maintenance: O C Initial Course Maint 1 week Q 2 weeks Q 3-4 weeks T 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

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

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

  24. 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

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

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

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

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