Accelerated Transcranial Magnetic Stimulation (TMS) for Depression (ATMS)
| Tracking Information | |||||
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| First Received Date ICMJE | November 2, 2005 | ||||
| Last Updated Date | March 14, 2012 | ||||
| Start Date ICMJE | February 2005 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hamilton Depression Scale [ Time Frame: 2-42 days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Hamilton Depression ScoreUnified Parkinson’s Disease Rating Scale | ||||
| Change History | Complete list of historical versions of study NCT00248768 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Clinical Global ImpressionRepeatable Battery for Assessment of Neurological StatusBrief Visuospatial Memory Test | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Accelerated Transcranial Magnetic Stimulation (TMS) for Depression | ||||
| Official Title ICMJE | Accelerated Transcranial Magnetic Stimulation for Depression | ||||
| Brief Summary | The purpose of this study is to determinate if accelerated rTMS treatment over 1.5 days is effective for ameliorating depression in Parkinson's disease. |
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| Detailed Description | Objective: The goal of this study is to investigate a new approach to administering repetitive transcranial magnetic stimulation (rTMS) in patients with refractory depression. (Please Note: The original requirement for comorbid Parkinson's disease has been dropped from this study). Research Plan: This inpatient study will provide an initial test for the hypothesis that accelerated rTMS is an effective treatment for depression. Followup testing will help delineate the time course of response. Methods: The rTMS treatment site over left dorsolateral prefrontal cortex will be 5.5cm anterior to the hand motor area. Treatments consisting of 1000 total pulses at 10 Hz and 100% motor threshold will be administered hourly for 1.5 days, totaling 15 sessions. A comprehensive test battery will be administered just before and after treatment, at 3 weeks, and at 6 weeks after treatment. Clinical Relevance: We expect that accelerated rTMS treatments will lessen the degree of depression to the same extent as rTMS treatments of longer duration, but far more rapidly. A much shorter hospitalization would be more easily tolerated. In addition, reducing the duration of hospitalization substantially reduces burdens and costs to hospital, staff, and caregivers, while more rapidly enhancing function and quality of life. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Device: Transcranial magnetic Stimulator
a device which produces intense magnetic fields in the brain and activates cerebral neurons |
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| Study Arm (s) | 1
Intervention: Device: Transcranial magnetic Stimulator |
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| Publications * | Holtzheimer PE 3rd, McDonald WM, Mufti M, Kelley ME, Quinn S, Corso G, Epstein CM. Accelerated repetitive transcranial magnetic stimulation for treatment-resistant depression. Depress Anxiety. 2010 Oct;27(10):960-3. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00248768 | ||||
| Other Study ID Numbers ICMJE | B3357-R, Emory IRB 601-2004, GCRC 4403E | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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