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Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01431001
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):

September 6, 2011
September 9, 2011
May 19, 2014
October 2011
October 2013   (Final data collection date for primary outcome measure)
Remission from depression [ Time Frame: baseline through 4 weeks post ]
Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post
Same as current
Complete list of historical versions of study NCT01431001 on ClinicalTrials.gov Archive Site
Safety and tolerability of rTMS [ Time Frame: baseline through 4 weeks post ]
Determined by presence and absence of adverse events recorded daily
Same as current
Not Provided
Not Provided
 
Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression
Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study
The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depressive Disorder
Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device
  • Experimental: Coil Configuration A
    Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
    Intervention: Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
  • Experimental: Coil Configuration B
    Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
    Intervention: Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Major depressive disorder (MDD)
  • Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode.
  • Will not become pregnant during study.

Exclusion Criteria:

  • Seizure disorder.
  • History of brain injury or active CNS disease.
  • Metal implants on or in brain, spinal cord, ear, eye or heart.
  • Current use of proconvulsant medications (e.g., bupropion).
  • Other significant psychiatric disorder.
  • Substance use disorder (not including caffeine or nicotine).
  • 7 or more failed treatment attempts for depression in one's lifetime.
  • Have failed to clinically remit to an adequate trial of ECT or TMS.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
 
 
NCT01431001
NS-CPS-TRMD-1
No
Not Provided
Not Provided
Cervel Neurotech, Inc.
Cervel Neurotech, Inc.
Not Provided
Study Chair: AnnaMarie Daniels Cervel Neurotech
Cervel Neurotech, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP