NCT00806143

Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Institute of Neuroscience, Florence, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Repetitive transcranial magnetic stimulation (rTMS) has been recently FDA approved for the treatment of resistant depression. No accordance exists on which are the involved mechanisms of action and on which stimulation parameters, frequency and side are optimal.

Detailed description

To compare these different procedures we study patients with unipolar recurrent resistant major depressive disorder in a double-blind, controlled trial randomized to either sequential bilaterally on the right and left dorsolateral prefrontal cortex (DLPFC) or monolaterally on the right DLPFC. Patients will be randomized to receive sequentially low-frequency rTMS at 1 Hz to the right DLPFC and high-frequency rTMS at 10 Hz rTMS to the left DLPFC, or to receive low-frequency rTMS at 1 Hz to the right DLPFC. Significant antidepressant effect as expressed by a reduction of Hamilton Depression Scale score will be recorded in both the groups of patients.

Conditions

• Major Depression

Interventions

Type	Name	Description
DEVICE	repetitive transcranial stimulation (rTMS)	Repetitive TMS will be administered using a MAGSTIM rapid magnetic stimulator (Magstim Company, Ltd., Whitland, U.K.) and a 70-mm figure-eight shaped coils. In monolateral treatment in right DLPFC, three 140-second trains will be applied at 1 Hz and at 110% of RMT. There is a 30 seconds intertrain interval (total of 420 stimuli per session). In sequential treatment, the stimulation will be applied in the first to the right and then to the left dorsolateral prefrontal cortex. In right DLPFC will be applied three 140-second trains at 1 Hz and at 110% of RMT. There will be a 30 seconds intertrain interval (total of 420 stimuli per session). In left DLPFC will be applied twenty 5-second trains were applied at 10 Hz and at 100% of RMT. There will be a 25-second intertrain interval (total of 1000 stimuli per session). Patients will be treated from Monday to Friday, for a total of 15 days.
DEVICE	unilateral stimulation	Patients will be treated from Monday to Friday, for a total of 15 days in the same timeframe of the active group right sided low frequency stimulation

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-12-10
• Last updated: 2011-02-24

Locations

1 site across 1 country: Italy