MedTrace Logo

Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder

NCT00927173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2020-07-15

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.

Conditions

Interventions

DEVICE

Brainsway H-Coil Deep TMS System

Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions

DEVICE

Brainsway H-Coil Deep TMS System (Sham treatment)

In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.

Sponsors & Collaborators

  • Brainsway

    lead INDUSTRY

Principal Investigators

  • Yechiel Levkovitz, M.D · Shalvat Mental Health Center

  • Abraham Zangen, Dr. · Weizmann Institute of Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • United States
  • Canada
  • France
  • Germany
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00927173 on ClinicalTrials.gov