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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
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.
Dr. Dancho Dilkov
Sofia, Bulgaria
Providence Care Mental Health Services
Kingston, Ontario, Canada
Clinician Administered PTSD Scale (CAPS) in both active and sham groups
Time frame: pre, week 2,4,6,8 & 12
Treatment Outcome PTSD scale (TOP-8)
Time frame: Pre, week 2,4,6,8 & 12
Hamilton Anxiety Scale
Time frame: Pre, week 2,4,6,8 & 12
Hamilton Depression Rating Scale
Time frame: Pre, week 2,4,6,8 & 12
Clinical Global Impression Scale (both severity and improvement)
Time frame: Pre, week 2,4,6,8 & 12
Social Functioning-36 Quality of Life Scale version(1)
Time frame: Pre, week 2,4,6,8 & 12
Pittsburgh Sleep Quality Index
Time frame: Pre, week 2,4,6,8 & 12
PTSD Checklist-civilian (PCL-C)
Time frame: Pre, week 2,4,6,8 & 12
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