F Andrew Kozel1, Michael A Motes2, Nyaz Didehbani2, Bambi DeLaRosa2, Christina Bass2, Caitlin D Schraufnagel2, Penelope Jones2, Cassie Rae Morgan2, Jeffrey S Spence2, Michael A Kraut3, John Hart4. 1. Mental Health and Behavioral Sciences & HSR&D Center of Innovation on Disability and Rehabilitation Research (CINDRR), James A. Haley Veterans' Hospital and Clinics, Tampa, FL, USA; Department of Psychiatry and Behavioral Sciences, University of South Florida, Tampa, FL, USA. Electronic address: fkozel@health.usf.edu. 2. University of Texas, Dallas, Dallas, TX, USA. 3. Department of Radiology and Radiologic Sciences, Johns Hopkins, University School of Medicine, Baltimore, MD, USA. 4. University of Texas, Dallas, Dallas, TX, USA; Depts. of Neurology and Neurotherapeutics and Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Abstract
BACKGROUND: The objective was to test whether repetitive Transcranial Magnetic Stimulation (rTMS) just prior to Cognitive Processing Therapy (CPT) would significantly improve the clinical outcome compared to sham rTMS prior to CPT in veterans with PTSD. METHODS:Veterans 18-60 years of age with current combat-related PTSD symptoms were randomized, using a 1:1 ratio in a parallel design, to active (rTMS+CPT) versus sham (sham+CPT) rTMS just prior to weekly CPT for 12-15 sessions. Blinded raters evaluated veterans at baseline, after the 5th and 9th treatments, and at 1, 3, and 6 months post-treatment. Clinician Administered PTSD Scale (CAPS) was the primary outcome measure with the PTSD Checklist (PCL) as a secondary outcome measure. The TMS coil (active or sham) was positioned over the right dorsolateral prefrontal cortex (110% MT, 1Hz continuously for 30min, 1800 pulses/treatment). RESULTS: Of the 515 individuals screened for the study, 103 participants were randomized to either active (n = 54) orsham rTMS (n = 49). Sixty-two participants (60%) completed treatment and 59 (57%) completed the 6-month assessment. The rTMS+CPT group showed greater symptom reductions from baseline on both CAPS and PCL across CPT sessions and follow-up assessments, t(df ≥ 325) ≤ -2.01, p ≤ 0.023, one-tailed and t(df ≥ 303) ≤ -2.14, p ≤ 0.017, one-tailed, respectively. LIMITATIONS: Participants were predominantly male and limited to one era of conflicts as well as those who could safely undergo rTMS. CONCLUSIONS: The addition of rTMS to CPT compared to sham with CPT produced significantly greater PTSD symptom reduction early in treatment and was sustained up to six months post-treatment.
RCT Entities:
BACKGROUND: The objective was to test whether repetitive Transcranial Magnetic Stimulation (rTMS) just prior to Cognitive Processing Therapy (CPT) would significantly improve the clinical outcome compared to sham rTMS prior to CPT in veterans with PTSD. METHODS: Veterans 18-60 years of age with current combat-related PTSD symptoms were randomized, using a 1:1 ratio in a parallel design, to active (rTMS+CPT) versus sham (sham+CPT) rTMS just prior to weekly CPT for 12-15 sessions. Blinded raters evaluated veterans at baseline, after the 5th and 9th treatments, and at 1, 3, and 6 months post-treatment. Clinician Administered PTSD Scale (CAPS) was the primary outcome measure with the PTSD Checklist (PCL) as a secondary outcome measure. The TMS coil (active or sham) was positioned over the right dorsolateral prefrontal cortex (110% MT, 1Hz continuously for 30min, 1800 pulses/treatment). RESULTS: Of the 515 individuals screened for the study, 103 participants were randomized to either active (n = 54) or sham rTMS (n = 49). Sixty-two participants (60%) completed treatment and 59 (57%) completed the 6-month assessment. The rTMS+CPT group showed greater symptom reductions from baseline on both CAPS and PCL across CPT sessions and follow-up assessments, t(df ≥ 325) ≤ -2.01, p ≤ 0.023, one-tailed and t(df ≥ 303) ≤ -2.14, p ≤ 0.017, one-tailed, respectively. LIMITATIONS: Participants were predominantly male and limited to one era of conflicts as well as those who could safely undergo rTMS. CONCLUSIONS: The addition of rTMS to CPT compared to sham with CPT produced significantly greater PTSD symptom reduction early in treatment and was sustained up to six months post-treatment.
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