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
1 other identifier
interventional
40
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Oct 2011
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2011
CompletedFirst Posted
Study publicly available on registry
September 9, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMay 19, 2014
May 1, 2014
2 years
September 6, 2011
May 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission from depression
Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post
baseline through 4 weeks post
Secondary Outcomes (1)
Safety and tolerability of rTMS
baseline through 4 weeks post
Study Arms (2)
Coil Configuration A
EXPERIMENTALCervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
Coil Configuration B
EXPERIMENTALCervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
Interventions
The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- or more failed treatment attempts for depression in one's lifetime.
- Have failed to clinically remit to an adequate trial of ECT or TMS.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Emory University
Atlanta, Georgia, 30306, United States
Rush Medical College
Chicago, Illinois, 60612, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
AnnaMarie Daniels
Cervel Neurotech
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2011
First Posted
September 9, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
May 19, 2014
Record last verified: 2014-05