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MILITARY
MEDICINE
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this study will concurrently receive trauma-focused therapy and Innovation
standard pharmacotherapy as a standard-of-care 30-day inpatient Innovative features of this proposal include: 1) neuronavigation
admission at the LRTC. Our study seeks to replicate and extend
the Cohen (et al., 2004) and Boggio et al. (2010) reports of right- using the UTHSCSA image-guided, robotic TMS delivery sys-
DLPFC TMS in PTSD, the trials with the largest effect sizes in tem; 2) 20-Hz stimulation protocol; 3) daily treatments (7
PTSD (Hedges G = 1.84 and 3.78, respectively). Stimulation will days/week) for 20 days; 4) inpatient cohort; and, 5) pre- and post-
use the 20-Hz protocol of Boggio rather than the 10 Hz protocol treatment fMRI to assess treatment mechanism of action.
used by Cohen. Novel aspects of the study are: 1) a cohort com-
posed of active-duty and veteran service members; 2) in-patient The UTHSCSA neuronavigation system has been subject to mul-
population; 3) use of image-guided neuronavigation and robotic tiple validations of its underlying theory (Fox et al., 2004, 2006;
TMS delivery; 4) treatment for 20 sessions over 3 weeks (7 daily Rabago et al., 2009; Sommer et al., 2012; Krieg et al., 2013) and
sessions/week) rather than 10 sessions over 2 weeks (5 daily ses- has been successfully applied in motor-learning trials (Narayana et
sions/week); 5) obtaining pre- and post-treatment imaging to de- al., 2014), lesion-deficit investigations (Narayana et al., 2009), and
termine the neurophysiological effects of this treatment protocol; network-property quantification in humans (Laird et al., 2008;
and 6) conducting a 3 month follow-up assessment. Narayana et al. 2012) and non-human primates (Salinas et al., 2011,
2013, 2016). This will be its first use in a controlled trial of a psy-
Participating Sites chiatric disorder. This will also be the first release of this UTHSCSA
This RCT is being performed as a collaboration between UT technology to an outside institution (LRTC).
Health San Antonio and Laurel Ridge Treatment Center. UTHSA Impact
provided the trial designed and oversees all aspects of the trial. The intended impact of this proposal is far reaching. Confirm-
Imaging, treatment planning and image analysis are performed at
the UTHSA Research Imaging Institute. Treatment delivery and ing prior estimates of the high effect size (3.78) of TMS in an ac-
symptom assessment are performed at LRTC. In preparation for tive-duty population would have substantial positive impact on
delivering irTMS treatments, an irTMS system (developed at the PTSD treatment options in both military and civilian popula-
RII) has been installed at LRTC and LRTC staff have been bully tions. A rapid (20 consecutive days) treatment protocol for short-
trained in its use. stay (~ 30 days) inpatients could have substantial therapeutic
impact on active-duty military and critical-duty civilian PTSD
Investigators patient populations. Confirming the efficacy of high-frequency
Peter T. Fox, M.D. is a neurologist, Director of the RII and co- TMS on a disorder characterized by diffuse hyperactivity would
be impactful both theoretically and practically. Providing quan-
inventor of irTMS. Jack L. Lancaster is a medical physicist spe- titative neuroimaging data on the mechanism of action, including
cializing in image-analysis algorithms and co-inventor of irTMS. symptoms corrections with path-specific effective-connectivity
John Roache, Ph.D. is a neuropharmacologist specializing in clin- adaptations would have substantial theoretical impact.
ical trial design. Felipe Salinas, Ph.D., is a biomedical engineer
with > 10 years of TMS training and experience, including elec- Military Relevance and Access to Military/
tromagnetic field modeling. Mary Unzueta, M.D., is a psychia- VA Populations
trist and Medical Director of the Mission Resiliency Program at
LRTC, an inpatient program that serves active-duty uniformed For active duty military personnel, a diagnosis of PTSD may
services members. affect all facets of military operations—including, but not limited
to, mission readiness and resource allocation. Although pharma-
ceutical and psychotherapeutic interventions are effective at re-
28 San Antonio Medicine • August 2017
