Fort Liberty

Researchers are evaluating the effectiveness of two telemedicine-delivered treatments, cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI), in adults with mild to moderate traumatic brain injury (TBI) who also have insomnia and post-traumatic stress symptoms. This prospective, single-blind randomized controlled trial will include 360 participants and aims to improve insomnia symptoms and reduce depressive symptoms. The study focuses on understanding how these therapies impact sleep severity and other related outcomes in this population. Participants will be randomly assigned to receive either a standardized 6-session CBT-I program or a 6-week MBTI program. CBT-I uses behavioral techniques to reduce arousal and improve sleep quality, while MBTI incorporates mindfulness meditation and behavioral strategies such as stimulus control and sleep restriction therapy. Both treatments are delivered remotely via telemedicine. Throughout the study, participants will wear an actigraph wrist monitor and complete electronic sleep diaries to track sleep patterns. Participants will undergo assessments including psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, and ambulatory EEG sleep monitoring at baseline, immediately after treatment, and at 2, 6, and 12 weeks post-treatment. The main outcome measured is the severity of insomnia using the Insomnia Severity Index (ISI). Secondary outcomes include pre-sleep arousal and depressive symptoms. The study also explores neurocognitive function and pre-sleep arousal changes, with safety and adherence monitored throughout the trial.

Researchers are evaluating the performance of the SavvyCheck Vaginal Yeast Test, a rapid, point-of-care diagnostic device designed for women to detect Candida antigen in vaginal secretions. The study aims to compare the accuracy of this test when performed by lay users to the standard vaginal Candida yeast culture method (the Reference Method), including analysis by polymerase chain reaction (PCR) and sequencing to understand discrepancies. The study includes both symptomatic and asymptomatic women aged 18 years and older, with a focus on vulvovaginal candidiasis, a common cause of vaginal yeast infections. Participants will use the SavvyCheck Vaginal Yeast Test, which detects Candida antigen through a swab of vaginal secretions. The test is intended for women experiencing symptoms such as increased vaginal discharge, itching, soreness, rash, and burning during urination. The study plans to enroll up to 600 symptomatic women to reach a target of 216 positive Reference Method results, and up to 320 asymptomatic women to reach 170 negative Reference Method results. Testing will be conducted at three military medical centers in the United States and Germany. During the study, women will perform the SavvyCheck test themselves, and results will be compared to the Reference Method culture results. Additional comparisons will include trained user-performed tests, vaginal wet mount microscopy, and PCR sequencing. Researchers will assess sensitivity, specificity, positive and negative predictive values, and concordance between methods. Participants will provide informed consent, and those currently menstruating or recently using vaginal products or medications will be excluded. The study monitors results over 12 months to evaluate test accuracy and reliability.

Researchers are evaluating the efficacy and comparative effectiveness of stellate ganglion block (SGB) and ketamine infusion, alone or combined, for treating post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI)-associated headaches. This phase 2, multicenter, randomized, double-blind, placebo-controlled trial addresses the lack of reliable treatments for these conditions, which are common injuries among deployed military personnel. The study also aims to explore structural and functional brain changes, biomarker levels, pain thresholds, and factors influencing treatment response to personalize therapy. A total of 175 eligible subjects will be randomly assigned to one of four groups: SGB plus placebo infusion, sham SGB plus ketamine infusion, SGB plus ketamine infusion, or sham SGB plus placebo infusion. The trial uses a 2:2:2:1 allocation ratio. Participants receive their assigned interventions and are monitored through several patient-reported outcomes at baseline, 1, 2, and 4 weeks. Those responding positively at 4 weeks continue follow-up visits at 8 and 12 weeks, with unblinding at 12 weeks and further monitoring at 6 and 12 months in an observational cohort. Participants with negative outcomes exit the trial but may receive other treatments as determined by their providers. Throughout the study, participants complete assessments including the Headache Impact Test (HIT-6) and PTSD Checklist (PCL-5) at 4 weeks as primary outcomes. Additional evaluations include quality of life measures, brain imaging, and biomarker analysis (except at one site). Safety and efficacy data are collected up to 12 months for those continuing with positive outcomes, while others are followed observationally to assess longer-term effects and potential alternative therapies.

This research aims to evaluate the effectiveness of a new ankle rehabilitation program called NATION in improving health and clinical outcomes for physically active adults with chronic ankle instability (CAI). CAI is a condition marked by repeated ankle sprains, instability, pain, and difficulty in movement, which limits activity and participation. The study focuses on physically active individuals including military personnel who are vulnerable to ankle injuries and explores whether incorporating neurocognitive tasks into rehabilitation can enhance recovery and reduce further injuries. Participants will be randomly assigned to one of three groups: the NATION intervention, an evidence-based rehabilitation program without neurocognitive tasks, or a control group receiving no treatment. Both NATION and evidence-based groups undergo a 6-week rehabilitation period including up to 12 supervised sessions and up to 18 home sessions focusing on range of motion, strength, balance, and ankle care. The NATION program uniquely adds neurocognitive exercises designed to improve thinking, reaction, and stability during movement. Participants will be assessed at the start, after 6 weeks, and at 6 months on measures such as ankle strength, balance, motor cognition, ankle range of motion, and sensory function. Self-reported pain, function, fear, quality of life, and injury history are also collected. Active-duty service members will report their confidence to deploy. Medical records will be monitored for up to 5 years for ankle surgery data. Workload and satisfaction with the rehabilitation programs will be evaluated during and after treatment to understand participant experience and outcomes.

Musculoskeletal injuries and traumatic brain injuries, especially concussions, are common and serious problems affecting military Service Members and physically active civilians. This research aims to understand the neuromuscular control problems that may increase the risk of musculoskeletal injuries after a concussion. The study compares concussed individuals to matched non-concussed controls to find differences that could explain the higher injury risk following concussion. Participants will undergo detailed biomechanical and neuromuscular testing at three time points: initially within five days of reporting asymptomatic after concussion, then at 6 weeks and 12 weeks after the first test. The assessments include jump-landing, single leg hop, anticipated cutting movements, single- and dual-task walking, muscle strength and activation tests, and sensory evaluations of proprioception and light touch sensation. Participants will also complete monthly self-reports on injuries and psychosocial health for up to one year. Throughout the study, researchers will measure changes in movement mechanics, muscle function, sensation, and patient-reported outcomes like physical function, pain interference, depression, anxiety, resilience, and fear of movement. These evaluations will help identify neuromuscular factors linked to injury risk after concussion and track how these factors change over time. The goal is to develop better ways to reduce injury risk in those recovering from concussion.

This research evaluates the safety and effect of erenumab, a calcitonin gene-related peptide (CGRP) monoclonal antibody, compared to placebo for treating acute posttraumatic headache (PTH) in military service members and civilians who have experienced mild traumatic brain injury (mTBI). The study is based on the idea that posttraumatic headache shares similarities with migraine and involves activation of the trigeminal vascular system and release of CGRP. It is a randomized, double-blind, placebo-controlled Phase 2 trial conducted at military treatment facilities across the United States. Participants receive either erenumab 140 mg or placebo delivered by subcutaneous injection. The study lasts for 12 weeks, during which participants are monitored under double-blind conditions, followed by a 4-week open-label safety extension to further assess tolerability. The trial compares the preventive treatment effects of erenumab against placebo in managing acute PTH. During the study, researchers track the number of monthly headache days from weeks 8 to 12 and monitor safety and tolerability. Participants must provide informed consent and have access to a personal healthcare provider for standard care of PTH and TBI. The study includes clinical evaluations, diagnostic procedures including neuroimaging as needed, and close monitoring throughout the treatment and extension periods.