Setting up a TMS Treatment Program Alvaro Pascual-Leone, M.D., - PowerPoint PPT Presentation

Setting up a TMS Treatment Program Alvaro Pascual-Leone, M.D., Ph.D. Daniel Cohen, M.D., M.M.Sc. Professor in Neurology Instructor in Neurology Harvard Medical School Harvard Medical School Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center

Contents  Safety and training of personnel  Equipment Starting program  Certification  Evaluation and Consent  Treatment Protocol  Assessment Managing patients  Maintenance  Cost/Billing  Future Developments Long term plans

Personnel  Clinicians (Neurology / Psychiatry)  Administrative support  Scheduling  Providing information to prospective patients  Data collection  Technicians  TMS trained  Basic Life Support  Patient interaction

Safety  Patient selection  Family history of epilepsy  Personal history of seizure/spells, head trauma, focal findings  Epileptogenic medications/combinations  Increased ICP, unstable cardiac disease  Metallic implants, aneurism clips, med pumps  TMS protocol- 10-20hz vs. 1hz

Safety cont ’ d  Seizure Response Protocol  Staff training in acute seizure response  Physician notification  Emergency medical services/code team  Equipment  Crash cart with benzodiazepines  Acetaminophen (headaches/neck pain)  Ear plugs

Equipment Air cooled coil to prevent overheating FDA-Approved Device (stimulator and coil) Peripheral Stimulation – Magstim, MagVentures, etc. Depression – Neuronetics (only one that can be advertised now)

Initial Evaluation  Referral from treating psychiatrist  Neurology  Contraindications  Effect of medication on TMS  Psychiatry  Caution if: Psychotic depression, bipolar, personality disorders  At least one adequate trial of antidepressant medication

Consent  Local ethical/safety committee (not IRB!)  Discussion of on-label * vs. off-label treatment * “ The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode .

Consent cont ’ d  Explanation of side-effects  Seizure  Headache  Neck pain  Scalp pain  Tinnitus/hearing  Cognitive side effects (theoretical)

Treatment Protocol Site Hemisphere Frequency Duration Waiting time Repetitions DLPFC Left 20 Hz 2 seconds 28 seconds 40 DLPFC Right 1 Hz 1600 seconds N/A 1 Both protocols give a total of 1600 pulses, Intensity is 110% of MT Neuronetics trial protocol: Left DLPFC 10 Hz, 4sec duration, 26 sec inter-train, total pulses: 3,000 per session 4-6 weeks

Induction Phase  Treatments daily (excluding weekends)  Mood assessed weekly  Duration: Minimum 2 weeks Mean 4 weeks Maximum 6 weeks

Assessment tools  Beck, Hamilton, Analogue scale  Target symptoms  Clinician evaluation of patient  Other sources of information (e.g. family, referring psychiatrist)  Side effects questionnaire  Weekly meeting of all staff to discuss progress

Maintenance Phase  Minimal evidence (absence of evidence, not evidence of absence)  Relapse prevention  Start with weekly treatment  Gradually space out sessions  “ Watchful Waiting ”  Patient presents when feeling worse

Cost  Insurance does not necessarily pay  $300/session magstim, $350 neuronetics  Additional fee for assessments  Helping with billing, talking with payers

Reimbursement for TMS  Currently its approved rarely on case-by-case basis  With FDA approval, carriers will be developing policies  Widespread acceptance and coverage still in future

Future Developments  Targeting (use of structural MRI ’ s and fMRI ’ s for intensity and targeting?)  More than one session/day  Interaction of rTMS with medications  Predictors of response  Monitoring response biologically  Other indications (pain, seizures, stroke recovery, Parkinson ’ s disease, bipolar)