Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Safety of the H1-Coil [ Time Frame: One Month ] [ Designated as safety issue: Yes ]maintaining subject's pre treatment, physical and neurological status.
- Clinical antidepressant response [ Time Frame: One Month ] [ Designated as safety issue: No ]a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.
- Clinical antidepressant remission [ Time Frame: One Month ] [ Designated as safety issue: No ]exit Hamilton Depression Rating Scale <9.
- Symptomatic improvement at the end point. [ Time Frame: One Month ] [ Designated as safety issue: No ]Change in Hamilton Anxiety Rating Scale (HARS), Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR), Clinical Global Impression (CGI).
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: elderly depressed patients
Twenty seven (27) patients aged 68 years or above, currently suffering from a major depressive episode, who did not respond to treatment with at least one antidepressant medications in the recommended dosage and duration, or could not tolerate at least two antidepressants.
Device: dTMS treatment (H1 Coil)
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.
|Contact: Dafna Shefet, MDfirstname.lastname@example.org|
|Shalvata Mental Health Center||Not yet recruiting|
|Hod Hasharon, Israel|
|Contact: Dafna Shefet, MD 972-9-7478524 email@example.com|
|Principal Investigator: Dafna Shefet, MD|