- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431001
Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression
May 15, 2014 updated by: Cervel Neurotech, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
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Melbourne, Victoria, Australia, 3004
- Monash Alfred Psychiatry Research Centre
-
-
-
-
Georgia
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Atlanta, Georgia, United States, 30306
- Emory University
-
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Medical College
-
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coil Configuration A
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)
|
The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline through 4 weeks post
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of rTMS
Time Frame: baseline through 4 weeks post
|
Determined by presence and absence of adverse events recorded daily
|
baseline through 4 weeks post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: AnnaMarie Daniels, Cervel Neurotech
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
September 6, 2011
First Submitted That Met QC Criteria
September 8, 2011
First Posted (Estimate)
September 9, 2011
Study Record Updates
Last Update Posted (Estimate)
May 19, 2014
Last Update Submitted That Met QC Criteria
May 15, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NS-CPS-TRMD-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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