Back to resultsEvaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
H1 -coil TMS device
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Depression
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of bipolar depression
Exclusion Criteria:
- No other axis I disorder
- Risk factors for convulsions
Sites / Locations
- Shalvata MHC
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00444938
First Posted
March 7, 2007
Last Updated
February 4, 2009
Sponsor
Shalvata Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT00444938
Brief Title
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression
Official Title
Evaluation of the H-Coil (TMS) Device - Safety and Feasibility in Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shalvata Mental Health Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the H-coil deep TMS device in bipolar depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
H1 -coil TMS device
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:
Diagnosis of bipolar depression
Exclusion Criteria:
No other axis I disorder
Risk factors for convulsions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eiran V Harel, MD
Organizational Affiliation
Shalvata MHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata MHC
City
Hod Hasharon
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
20854181
Citation
Harel EV, Zangen A, Roth Y, Reti I, Braw Y, Levkovitz Y. H-coil repetitive transcranial magnetic stimulation for the treatment of bipolar depression: an add-on, safety and feasibility study. World J Biol Psychiatry. 2011 Mar;12(2):119-26. doi: 10.3109/15622975.2010.510893. Epub 2010 Sep 21.
Results Reference
derived
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Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression
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