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

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.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beer-Yaacov MHC

Beer Yaacov, 70350, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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)

Time frame: 2 months

Sponsors and collaborators

Lead sponsor

BeerYaakov Mental Health Center

Other Gov

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Dec 19, 2007
Registry last updated: Oct 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed