NCT00577070

Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: BeerYaakov Mental Health Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

There is a general consensus of efficacy of TMS in treatment of major depression,yet results are not satisfying.A new coil ("H"-coil, recently invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) is supposed to be capable of stimulating deeper brain structures than conventional coils.TMS using this coil was named by its developers as "deep TMS" and will hence be refered to by this name. So far, deep TMS have studied in Israel with promising sucssess in patients with Major depression (An on-going study).A safety study with good results have been recently published.The aim of this study is to reinforce initial results in major depression using deep TMS.

Detailed description

A group of 40 patients with major depression will be randomly assigned to deep TMS with H-1 coil in frequency of 20 HZ or H-2 coil in frequency of 0.1 HZ with 120% of motor threshold to the prefrontal cortex . No change in anti-depressant medication one month prior to study is a prerequisite.Deep TMS will be administered for 4 weeks.During TMS exposure subjects will be exposed to a conversation in which they talk about their depression and their ruminations.Patients will be evaluated using Hamilton Depression Rating Scale (HAM-D24),Hamilton Anxiety Rating Scale (HAM-A),Clinical Global Impression - Improvement(CGI-I) ,Beck Depression Inventory (BDI),Visual Analog Scale (VAS).

Conditions

• Major Depression

Interventions

Type	Name	Description
DEVICE	TMS	Transcranial Magnetic Stimulation (TMS) is a new tool in neuropsychiatry. This method is based on creating pre determined magnetic fields, which alternate rapidly. The magnetic fields are intended to cause electric induction in the brain cells and, as a consequence, generation of action potentials. The magnetic stimulation is delivered/ generated by a coil, positioned on the patient's scalp, inducing nerve stimulation within the brain. Therefore, when placed over the motor cortex, the magnetic stimulation creates Muscular Evoked potential, which can be measured by EMG.

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-12-19
• Last updated: 2009-10-06

Locations

1 site across 1 country: Israel