Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression
Major Depression
About this trial
This is an interventional treatment trial for Major Depression
Eligibility Criteria
Inclusion Criteria:
- Right handed ,18-65 year old male or female subjects
- Diagnosed according to DSM-V-TR as suffering from Major depression using SCID interview
- Score of 22 or more in the Hamilton Depression Rating Scale (HAM-D24)
- The present depressive episode have been treated with at least 2 different anti-depressive drugs at peak doses for at least 6 weeks with not more than a partial response.Augmentation strategies may be included.
Exclusion Criteria:
Cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma patients suffering from chronic medical conditions of any sort:
- History of current hypertension
- History of seizure or heat convulsion
- History of epilepsy or seizure in first degree relatives
- History of head injury
- History of any metal in the head (outside the mouth)
- Known history of any metallic particles in the eye
- Implanted cardiac pacemaker or any intra-cardiac lines
- Implanted neuro-stimulators
- Surgical clips or any medical pumps
- History of frequent or severe headaches
- History of migraine
- History of hearing loss
- Known history of cochlear implants
- History of drug abuse or alcoholism
- Pregnancy or not using a reliable method of birth control (non-pregnancy will be proved by beta-HCG test)
- Systemic and metabolic disorders
- Inadequate communication skills or under custodial care.
Sites / Locations
- Beer-Yaacov MHC
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
H1
H2
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.
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.