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

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
H1 and H2 deep TMS coils
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring major depression, TMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shalvata MHC

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2007
Last Updated
February 4, 2009
Sponsor
Shalvata Mental Health Center
Collaborators
Brainsway
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1. Study Identification

Unique Protocol Identification Number
NCT00445237
Brief Title
Evaluation of Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression
Official Title
Evaluation of the H1 Coil and H2 Coil TMS Device - Safety and Feasibility in Major Depression Episode
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shalvata Mental Health Center
Collaborators
Brainsway

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
major depression, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
H1 and H2 deep TMS coils

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilik Levkovits
Organizational Affiliation
Day care hospital director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata MHC
City
Hod Hasharon
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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