Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in elderly patients suffering from major depressive episode. Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above, currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be conducted before starting the trial (screening), once a week for the trial duration and one month following end of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.
Shalvata Mental Health Center
Hod HaSharon, Israel
Safety of the H1-Coil
maintaining subject's pre treatment, physical and neurological status.
Time frame: One Month
Clinical antidepressant response
a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.
Time frame: One Month
Clinical antidepressant remission
exit Hamilton Depression Rating Scale \<9.
Time frame: One Month
Symptomatic improvement at the end point.
Change in Hamilton Anxiety Rating Scale (HARS), Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR), Clinical Global Impression (CGI).
Time frame: One Month
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