Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for 6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD Scale (CAPS) in both active and control groups.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Experimental | Repetitive Transcranial Magnetic Stimulation |
|
| 2 | Sham Comparator | Device: Sham (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic) | Device | 6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the 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. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) in both active and sham groups | pre, week 2,4,6,8 & 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Outcome PTSD scale (TOP-8) | Pre, week 2,4,6,8 & 12 | |
| Hamilton Anxiety Scale | Pre, week 2,4,6,8 & 12 | |
| Hamilton Depression Rating Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roumen Milev, MD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Dancho Dilkov | Sofia | Bulgaria | ||||
| Providence Care Mental Health Services |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Pre, week 2,4,6,8 & 12 |
| Clinical Global Impression Scale (both severity and improvement) | Pre, week 2,4,6,8 & 12 |
| Social Functioning-36 Quality of Life Scale version(1) | Pre, week 2,4,6,8 & 12 |
| Pittsburgh Sleep Quality Index | Pre, week 2,4,6,8 & 12 |
| PTSD Checklist-civilian (PCL-C) | Pre, week 2,4,6,8 & 12 |
| Kingston |
| Ontario |
| K7L 4X3 |
| Canada |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
Not provided
Not provided