Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

File3

372 views

Published on

Published in: Health & Medicine
  • Be the first to comment

  • Be the first to like this

File3

  1. 1. Deep Transcranial MagneticDeep Transcranial Magnetic Stimulation for Acute &Stimulation for Acute & Maintenance Treatment inMaintenance Treatment in DepressionDepression Dr.Dr. Levkovitz Y.Levkovitz Y. Cognitive and Emotional Laboratory,Cognitive and Emotional Laboratory, Shalvata Mental Health Center,Shalvata Mental Health Center, School of Medicine, Tel Aviv University, Israel.School of Medicine, Tel Aviv University, Israel.
  2. 2. Overview of Clinical Trials • Safety (n=9 ).Safety (n=9 ). • Open pilot (Open pilot (feasibility, n=9) ., n=9) . • Controlled, multi-center (efficacy)Controlled, multi-center (efficacy)
  3. 3. Open Pilot inOpen Pilot in Acute &Acute & Maintenance Treatment inMaintenance Treatment in DepressionDepression Purpose:Purpose: Evaluate the feasibilityEvaluate the feasibility and safety of the H-Coil inand safety of the H-Coil in AcuteAcute & Maintenance Treatment in& Maintenance Treatment in DepressionDepression
  4. 4. H1 Coil (120% MT) E [V/m] RED ANDRED AND ORANGEORANGE COLORSCOLORS REPRESENTREPRESENT BRAINBRAIN ACTIVATIONACTIVATION Phantom Brain MeasurementsPhantom Brain Measurements Electric field distribution of the H coils and figure of 8 at 120% MT Figure of 8 Coil (120% MT) While figure of 8 stimulate 1- 1.5 cm the H coils reach to 5-6 cm beneath the cortex Roth et al. J. Clin. Neurophysiology 2007
  5. 5. Inclusion CriteriaInclusion Criteria:: 18-65 years.18-65 years. Diagnosed as suffering from aDiagnosed as suffering from a depressive episode according to DSM IVdepressive episode according to DSM IV using the (SCID).using the (SCID). Rating onRating on HADRS->20HADRS->20.. Treated for the current depressiveTreated for the current depressive episode, at least 5 weeks perepisode, at least 5 weeks per antidepressant with two antidepressantantidepressant with two antidepressant (ATHF>3).(ATHF>3). Negative answers on safety screeningNegative answers on safety screening questionnaire for TMS.questionnaire for TMS. Acute & Maintenance Treatment in Depression. Safety and feasibility study
  6. 6. N=9 Clinical Assessments were carried out once a week. Cognitive Assessments were carried out at screening day And after the last treatment. Prospective, Feasibility and Safety StudyProspective, Feasibility and Safety Study in Acute & Maintenance Treatment inAcute & Maintenance Treatment in DepressionDepression Prefrontal rTMS (42 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, 120% of motor threshold) each morning for 4 consecutive weeks (5 days a week), followed by 8 weeks (2 days a week) and 10 weeks (1 day a week). Day -0 Screening Maintenance Phase: 4weeks of dTMS 5 days a week. H1-120% Acute & Maintenance Treatment in Depression. Safety and feasibility study. 8weeks of dTMS 2days a week. 10weeks of dTMS 1day a week. Acute Phase:
  7. 7. Primary Objective :Primary Objective : 11..Safety of theSafety of the H1H1 coil acute and maintenance treatment ascoil acute and maintenance treatment as defined by maintained subject baseline, pre treatment,defined by maintained subject baseline, pre treatment, physical and neurological statusphysical and neurological status.. 22..Clinical antidepressantClinical antidepressant responseresponse at the end of the acuteat the end of the acute treatment, and during the maintenance phase, defined astreatment, and during the maintenance phase, defined as a decline in Hamilton depression rating scale from thea decline in Hamilton depression rating scale from the baseline rating by 50%baseline rating by 50%.. Secondary Objectives:Secondary Objectives: 11..Clinical antidepressantClinical antidepressant remissionremission at the end of theat the end of the treatment, defined as exit Hamilton Depression Ratingtreatment, defined as exit Hamilton Depression Rating Scale <8Scale <8.. 22..Symptomatic improvement at the end point as measuredSymptomatic improvement at the end point as measured with Hamilton Anxiety Rating Scale (HARS), Beckwith Hamilton Anxiety Rating Scale (HARS), Beck Depression Inventory (BDI), and Clinical GlobalDepression Inventory (BDI), and Clinical Global Impression (CGIImpression (CGI).). Acute & Maintenance Treatment in Depression. Safety and feasibility study
  8. 8. Demographic and BaselineDemographic and Baseline CharacteristicsCharacteristics Characteristic Mean (SD) Age, yAge, y 45.12 (12.21)45.12 (12.21) Sex M/F, NoSex M/F, No.. 3/63/6 Baseline HDRSBaseline HDRS 25.67 (3.46)25.67 (3.46) Baseline BDIBaseline BDI 32.44 (9.96)32.44 (9.96) Baseline HARSBaseline HARS 14.3314.33))6.606.60(( Baseline CGIBaseline CGI 4.78 (0.44)4.78 (0.44) Acute & Maintenance Treatment in Depression. Safety and feasibility study
  9. 9. Clinical Characteristics of Patients CharacteristicCharacteristic Mean (SD)Mean (SD) Age at onset (years)Age at onset (years) 27.6727.67±±8.838.83 Duration of currentDuration of current episode (monthsepisode (months)) 12.9612.96±±8.368.36 Number of past episodesNumber of past episodes 6.606.60±±4.824.82 Number of hospitalizationsNumber of hospitalizations 1.881.88±±3.013.01 Number of suicideNumber of suicide attemptsattempts 00 Acute & Maintenance Treatment in Depression. Safety and feasibility study
  10. 10. Results: Significant improvement in HDRS when comparing baseline and end of the acute phase Acute & Maintenance TreatmentAcute & Maintenance Treatment in Depressionin Depression.. Open study Acute & Maintenance Treatment in DepressionAcute & Maintenance Treatment in Depression.. feasibility study Hamilton Depression Rating Scale (HDRS) in Acute PhaseHamilton De pre ssion Rating Scale (Acute Phase ) 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 screening 1 4 10 15 20 Visit numbe r TotalScoreHDRS Severe depression (>24( Moderate depression (18-24( Mild depression (<18(
  11. 11. Results: Acute & Maintenance TreatmentAcute & Maintenance Treatment in Depressionin Depression.. Open study Acute & Maintenance Treatment in DepressionAcute & Maintenance Treatment in Depression.. Safety and feasibility study Hamilton Depression Rating Scale (HDRS) in Maintenance Phase Hamilton Depression Rating Scale (Maintanance Phase) 0 2 4 6 8 10 12 14 16 22 24 26 28 30 32 34 36 37 Visit number TotalScoreHDRS Mild depression (<18(
  12. 12. Results: Acute & Maintenance TreatmentAcute & Maintenance Treatment in Depressionin Depression.. Open study Acute & Maintenance Treatment in DepressionAcute & Maintenance Treatment in Depression.. Safety and feasibility study HamiltonAnxietyRatingScale (Acute Phase) 0 2 4 6 8 10 12 14 16 18 screening 1 4 10 15 20 Visit number TotalScoreHAM-A Hamilton anxiety Rating Scale (HAM-A) in Acute Phase Hamilton anxiety Rating Scale (HAM-A) in Maintenance Phase mild anxiety (<17( HamiltonAnxietyRatingScale (Maintenance Phase) 0 2 4 6 8 10 12 14 16 18 22 24 26 28 30 32 34 36 37 Visit number TotalScoreHAM-A mild anxiety (<17(
  13. 13. Results: Acute & Maintenance TreatmentAcute & Maintenance Treatment in Depressionin Depression.. Open study Acute & Maintenance Treatment in DepressionAcute & Maintenance Treatment in Depression.. Safety and feasibility study BeckDepressionInventory(Acute Phase) 0 5 10 15 20 25 30 35 40 screening 1 4 10 15 20 Visitnumber TotalscoreBDI Severe(>29) Moderate(20-28) Mild(14-19) Beck Depression Inventory (BDI) Acute Phase Beck Depression Inventory (BDI) maintenance Phase Beck DepressionInventory(Maintenance Phase) 0 5 10 15 20 25 30 35 22 24 26 28 30 32 34 36 37 Visitnumber TotalScoreBDI Severe (>29) Moderate (20-28) Mild (14-19)
  14. 14. Clinical Global Impression (CGI) in Maintenance Phase Clinical Global Impression (CGI) in Acute Phase Results: Improvement in depression was also reflected by the Clinical Global Impression Scale Bipolar depression feasibility study Clinical Globlal Impression- Severity (Acute Phase) 0.00 1.00 2.00 3.00 4.00 5.00 6.00 screening 1 4 10 15 20 Visit number TotalScoreCGIS ClinicalGloblalImpression- Severity(Maintenance Phase) 0 1 2 3 4 5 22 24 26 28 30 32 34 36 37 Visit number TotalScoreCGIS
  15. 15. H coil effect on Executive Functions in BipolarH coil effect on Executive Functions in Bipolar DepressionDepression Working Memory (SWM) Planning (SOC) Inhibition
  16. 16. LimitationLimitation:: • No sham control.No sham control.
  17. 17. Thanks !Thanks ! Shalvata MentalShalvata Mental Health CenterHealth Center Dr. E. HarelDr. E. Harel Dr. Y. BrawY. Braw Neurobiology Dep. Weizmann InstNeurobiology Dep. Weizmann Inst.. A.A.Zanegn and Y. RothZanegn and Y. Roth

×