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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier:
NCT01431001
First received: September 6, 2011
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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 Intervention
Major Depressive Disorder
Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study

Further study details as provided by Cervel Neurotech, Inc.:

Primary Outcome Measures:
  • Remission from depression [ Time Frame: baseline through 4 weeks post ] [ Designated as safety issue: No ]
    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:
  • Safety and tolerability of rTMS [ Time Frame: baseline through 4 weeks post ] [ Designated as safety issue: Yes ]
    Determined by presence and absence of adverse events recorded daily


Enrollment: 40
Study Start Date: October 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier: NCT01431001     History of Changes
Other Study ID Numbers: NS-CPS-TRMD-1
Study First Received: September 6, 2011
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board
Australia: Human Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 20, 2014