Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression
This study is currently recruiting participants.
Verified October 2012 by Cervel Neurotech, Inc.
Sponsor:
Cervel Neurotech, Inc.
Information provided by (Responsible Party):
Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier:
NCT01431001
First received: September 6, 2011
Last updated: October 4, 2012
Last verified: October 2012
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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 |
Resource links provided by NLM:
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
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Coil Configuration A |
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 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431001
Locations
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30306 | |
| Contact: Sabrina Stair 404-728-6856 sstair@emory.edu | |
| Principal Investigator: William M McDonald, MD | |
| United States, Illinois | |
| Rush Medical College | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Amy Rust, RN 888-762-7272 Amy_Rust@rush.edu | |
| Principal Investigator: Philip G Janicak, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Completed |
| Charleston, South Carolina, United States, 29425 | |
| Australia, Victoria | |
| Monash Alfred Psychiatry Research Centre | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: David Elliot 61 3 9076 6595 d.elliot@alfred.org.au | |
| Principal Investigator: Paul Fitzgerald, MBBS, PhD | |
Sponsors and Collaborators
Cervel Neurotech, Inc.
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: | October 4, 2012 |
| 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:
|
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013