Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly
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|ClinicalTrials.gov Identifier: NCT01521052|
Recruitment Status : Unknown
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was: Not yet recruiting
First Posted : January 30, 2012
Last Update Posted : January 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Device: dTMS treatment (H1 Coil)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2012|
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.
- Safety of the H1-Coil [ Time Frame: One Month ]maintaining subject's pre treatment, physical and neurological status.
- Clinical antidepressant response [ Time Frame: One Month ]a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.
- Clinical antidepressant remission [ Time Frame: One Month ]exit Hamilton Depression Rating Scale <9.
- Symptomatic improvement at the end point. [ Time Frame: One Month ]Change in Hamilton Anxiety Rating Scale (HARS), Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR), Clinical Global Impression (CGI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521052
|Contact: Dafna Shefet, MDemail@example.com|
|Shalvata Mental Health Center||Not yet recruiting|
|Hod Hasharon, Israel|
|Contact: Dafna Shefet, MD 972-9-7478524 firstname.lastname@example.org|
|Principal Investigator: Dafna Shefet, MD|