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

Major Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577070
• Other study ID #: TMS-204CTIL
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2007
• Last updated: October 5, 2009
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2009
• Source: BeerYaakov Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Major Depression

Intervention

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.

Locations

Country	Name	City	State
Israel	Beer-Yaacov MHC	Beer Yaacov

Sponsors (1)

Lead Sponsor	Collaborator
BeerYaakov Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No