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| Name | Class |
|---|---|
| Military Medical Academy, Bulgaria | OTHER |
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This study will compare the change detected by a standardized rating scale (Hamilton Anxiety Rating Scale) scores in the active treatment group as compared to sham (placebo) group after 6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to improvement of core symptoms in patients with GAD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation | Device | 6 weeks of repetitive transcranial magnetic stimulation . Treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of MT, 20 trains, 9 sec/train, 51 sec ITI applied over right dorsolateral prefrontal cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Anxiety Rating Scale (ham-a) | baseline, week 2, 4, 6, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression | baseline, 2, 4, 6, 8, 12 | |
| Hamilton Depression Rating Scale-21 | baseline, week 2, 4, 6, 8, 12 | |
| Pittsburgh Sleep Quality Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roumen Milev, MD | Queen's University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Medical Academy | Sofia | Bulgaria | ||||
| Providence Care Mental Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28533148 | Derived | Dilkov D, Hawken ER, Kaludiev E, Milev R. Repetitive transcranial magnetic stimulation of the right dorsal lateral prefrontal cortex in the treatment of generalized anxiety disorder: A randomized, double-blind sham controlled clinical trial. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Aug 1;78:61-65. doi: 10.1016/j.pnpbp.2017.05.018. Epub 2017 May 19. |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| placebo sham | Device | Sham treatment will mimic active treatment mentioned above. |
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| baseline, week 2, 4, 6, 8, 12 |
| SF-36 QOL version (1) | baseline, week 2, 4, 6, 8, 12 |
| Visual Analogue Scales | baseline, week 2, 4, 6, 8, 12 |
| Kingston |
| Ontario |
| K7L4X3 |
| Canada |