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

This study has been completed.
Sponsor:
Collaborator:
Brainsway
Information provided by:
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT00445237
First received: March 7, 2007
Last updated: February 4, 2009
Last verified: March 2007
  Purpose

This study is evaluating the safety and feasibility of the novel deep TMS H-coil designs in the treatment of resistant major depression in an open study using two different H-coil designs.


Condition Intervention Phase
Major Depression
Device: H1 and H2 deep TMS coils
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the H1 Coil and H2 Coil TMS Device - Safety and Feasibility in Major Depression Episode

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Study Start Date: May 2006
Study Completion Date: March 2008
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed as suffering from treatment resistant major depression

Exclusion Criteria:

  • Other axis I diagnosis
  • Risk factors for convulsions
  • Electroconvulsive therapy (ECT) in the last 9 months
  • History of drug abuse in the past year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445237

Locations
Israel
Shalvata MHC
Hod Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Brainsway
Investigators
Principal Investigator: Hilik Levkovits Day care hospital director
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00445237     History of Changes
Other Study ID Numbers: SH-505
Study First Received: March 7, 2007
Last Updated: February 4, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
major depression
TMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014