NCT01521052

Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Shalvata Mental Health Center · Academic / Other
• Sex: All
• Age: 68 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• First posted: 2012-01-30
• Last updated: 2012-01-30

Locations

1 site across 1 country: Israel