Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H1 | Active Comparator | Includs 20 patients.These patients will be given 4 weeks (5 days a week) of deep TMS,20 minutes each session, to the left prefrontal cortex using H1 coil, in frequency of 20 HZ, with intensity of 120 % of motor threshold. H1-coil is an extracorporeal device positioned on the patient's scalp, designed to stimulate deep prefrontal brain regions, preferentially in the left hemisphere. The effective part of the coil, which has contact with the patient's scalp, includes 14 strips of 7-12 cm length. These strips are oriented in an anterior-posterior axis.This coil stimulates neuronal fibers in anterior-posterior orientation. During deep TMS exposure patients will listen to a clinical interview in which they describe the different expressions of their depression including their ruminations and depressive schemas. |
|
| H2 | Experimental | Includs 20 patients.These patients will be given 4 weeks (5 days a week) of deep TMS, 20 minutes each session, to the prefrontal cortex bilateraly using H2 coil, in frequency of 0.1 HZ, with intensity of 120 % of motor threshold. H2-coil is designed to stimulate deep prefrontal brain regions bilaterally (without any preferencefor either hemisphere). The effective part of the coil, which has contact with the patient's scalp, includes 10 strips of 14-22 cm length.These strips are oriented in a right-left direction (lateral-medial axis).This coil is destined to stimulate lateral-medial neuronal fibers. During deep TMS exposure patients will listen to a clinical interview in which they describe the different expressions of their depression including their ruminations and depressive schemas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response defined as at least a 50% decrease in Hamilton Depression Rating Scale (HAM-D24). Remission is defined as below 8 in Hamilton Depression Rating Scale (HAM-D24) | 2 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma patients suffering from chronic medical conditions of any sort:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Oded Rosenberg, M.D. | Beer Yaakov Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beer-Yaacov MHC | Beer Yaacov | 70350 | Israel |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|