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Deep brain stimulation of the basolateral amygdala for treatment-refractory combat post-traumatic stress disorder (PTSD): Study protocol for a pilot randomized controlled trial with blinded, staggered onset of stimulation
Background: Combat post-traumatic stress disorder (PTSD) involves significant suffering, impairments in social and occupational functioning, substance use and medical comorbidity, and increased mortality from suicide and other causes. Many veterans continue to suffer despite current treatments. Deep brain stimulation (DBS) has shown promise in refractory movement disorders, depression and obsessive-compulsive disorder, with deep brain targets chosen by integration of clinical and neuroimaging literature. The basolateral amygdala (BLn) is an optimal target for high-frequency DBS in PTSD based on neurocircuitry findings from a variety of perspectives. DBS of the BLn was validated in a rat model of PTSD by our group, and limited data from humans support the potential safety and effectiveness of BLn DBS.Methods/Design: We describe the protocol design for a first-ever Phase I pilot study of bilateral BLn high-frequency DBS for six severely ill, functionally impaired combat veterans with PTSD refractory to conventional treatments. After implantation, patients are monitored for a month with stimulators off. An electroencephalographic (EEG) telemetry session will test safety of stimulation before randomization to staggered-onset, double-blind sham versus active stimulation for two months. Thereafter, patients will undergo an open-label stimulation for a total of 24 months. Primary efficacy outcome is a 30% decrease in the Clinician Administered PTSD Scale (CAPS) total score. Safety outcomes include extensive assessments of psychiatric and neurologic symptoms, psychosocial function, amygdala-specific and general neuropsychological functions, and EEG changes. The protocol requires the veteran to have a cohabiting significant other who is willing to assist in monitoring safety and effect on social functioning. At baseline and after approximately one year of stimulation, trauma script-provoked 18FDG PET metabolic changes in limbic circuitry will also be evaluated.Discussion: While the rationale for studying DBS for PTSD is ethically and scientifically justified, the importance of the amygdaloid complex and its connections for a myriad of emotional, perceptual, behavioral, and vegetative functions requires a complex trial design in terms of outcome measures. Knowledge generated from this pilot trial can be used to design future studies to determine the potential of DBS to benefit both veterans and nonveterans suffering from treatment-refractory PTSD
U–Pb zircon and biostratigraphic data of high-pressure/low-temperature metamorphic rocks of the Talea Ori: tracking the Paleotethys suture in central Crete, Greece
Inherited deformation microfabrics of detrital quartz grains and U–Pb (Laser ablation (LA)-ICPMS and ID TIMS) ages of detrital zircons separated from the Phyllite–Quartzite Unit s.l. of the Talea Ori, central Crete, suggest strikingly different source rocks. Albite gneiss of the lower Rogdia Beds includes Cambrian and Neoproterozoic rounded zircons with main U–Pb age peaks at 628 and 988 Ma. These and minor Paleoproterozoic and Archean peaks, together with the lack of Variscan-aged and Mesoproterozoic zircons, are similar to the age spectra obtained from the Phyllite–Quartzite Unit s.str. of the Peloponnesus and eastern Crete and from the Taurides. All of these zircons should be derived from the northeastern passive margin of Gondwana (Cimmeria). Metatuffites of the uppermost Rogdia Beds and metasandstone of Bali beach, on the other hand, include euhedral detrital zircons displaying a Variscan U–Pb age spectra at ca. 300 Ma with concordia ages at 291 ± 3, 300 ± 1 Ma (Rogdia) and 286 ± 3, 300 ± 3, 313 ± 2 Ma (Bali). Both types of metasediments and their zircons are similar to those of the pre-Alpine basement and overlying Tyros Beds of eastern Crete, revealing a provenance at the southern active margin of Laurasia. Thus, in central Crete the Paleotethys suture should be situated inside the Rogdia Beds. Magmatic zircons separated from a rhyolite boulder of the lower Achlada Beds yielded a concordant U–Pb zircon age at 242 ± 2 Ma placing a maximum age for the deposition of the (meta) conglomerate from which the boulder was collected. This age is compatible with an Olenekian-early Anisian age of the underlying Vasilikon marble suggested by new findings of the foraminifera Meandrospira aff. pusilla. Both the Achlada Beds and the Vasilikon marble can be attributed to the lower Tyros Beds of eastern Crete. The Alpine deformation led to a pervasive mylonitic foliation, which is affecting most of the studied rocks. This foliation results from D2 top-to-the-north shearing, which post-dates the growth of blue amphiboles (crossite)