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CompletedNCT00444938Updated Feb 5, 2009

Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression

A Phase 1 interventional study of H1 -coil TMS device in Bipolar Depression, sponsored by Shalvata Mental Health Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-02-05.

Sponsored by Shalvata Mental Health Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

Browse Depression studies →

Lead sponsor

Shalvata Mental Health Center is the lead sponsor of 73 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of bipolar depression

Exclusion criteria

Exclusion Criteria:

  • No other axis I disorder
  • Risk factors for convulsions
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • DeviceH1 -coil TMS device
06

Study locations

1 site
  • Shalvata MHC
    Hod Hasharon, Israel
07

References and documents

Publications

  • 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. PubMed 20854181 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00444938
Lead sponsor
Shalvata Mental Health Center
First posted
Mar 8, 2007
Start date
Jun 2006
Completion
Mar 2008
Last update
Feb 5, 2009

Study contacts

Eiran V Harel, MD
principal investigator · Shalvata MHC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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