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

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ClinicalTrials.gov Identifier: NCT01431001
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Cervel Neurotech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study
Study Start Date : October 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Coil Configuration A
Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
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 B
Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety and tolerability of rTMS [ Time Frame: baseline through 4 weeks post ]
    Determined by presence and absence of adverse events recorded daily



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431001


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30306
United States, Illinois
Rush Medical College
Chicago, Illinois, United States, 60612
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Australia, Victoria
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Cervel Neurotech, Inc.
Investigators
Study Chair: AnnaMarie Daniels Cervel Neurotech

Responsible Party: Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier: NCT01431001     History of Changes
Other Study ID Numbers: NS-CPS-TRMD-1
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

Keywords provided by Cervel Neurotech, Inc.:
Depression
MDD
Transcranial Magnetic Stimulation
Depressive Disorder
TMS

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