Fort Liberty

Researchers are investigating the effectiveness of two telemedicine-delivered treatmentscognitive behavioral therapy for insomnia CBT-I and mindfulness-based treatment for insomnia MBTIin adults with mild to moderate traumatic brain injury TBI who also have symptoms of post-traumatic stress and insomnia. The study is a prospective, randomized, single-blind controlled trial including 360 participants, aiming to compare how these treatments reduce insomnia severity and depressive symptoms. Participants are randomly assigned to receive either CBT-I or MBTI, each delivered in six standardized sessions via telemedicine. CBT-I focuses on education about sleep, stimulus control, sleep restriction, relaxation training, and cognitive restructuring over six weeks. MBTI integrates mindfulness meditation practices with behavioral sleep strategies during the same 6-week period. Throughout the study, participants wear an actigraph wrist monitor and keep electronic sleep diaries to track sleep patterns and treatment adherence. Participants will complete assessments including psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, and ambulatory EEG sleep monitoring at baseline, end of treatment, and at 2, 6, and 12 weeks post-treatment. The main outcome measured is insomnia severity using the Insomnia Severity Index. Secondary outcomes include pre-sleep arousal and depressive symptoms. The study monitors participants for a total of 24 weeks after randomization to evaluate treatment effects and safety.

This research aims to establish performance standards for the SavvyCheck Vaginal Yeast Test when used by lay users compared to the standard vaginal yeast culture method for detecting Candida. The study focuses on both symptomatic and asymptomatic women, using additional methods like PCR and fungal sequencing to understand discrepancies between test results. It evaluates sensitivity, specificity, predictive values, and agreement between different test performers and methods. Participants will use the SavvyCheck Vaginal Yeast Test, a rapid, over-the-counter device that detects Candida antigen from vaginal swabs. The study enrolls women with and without symptoms of vulvovaginal candidiasis, targeting specific numbers to achieve positive and negative reference culture results. This observational study is conducted at multiple military treatment facilities, involving both lay users and trained users performing the test for comparison. During the study, participants will have evaluations including the SavvyCheck test performed by themselves and trained users, vaginal yeast cultures, wet mount microscopy, and PCR with sequencing when needed. Researchers will assess test accuracy, agreement of results, and predictive values over 12 months. Women must provide informed consent and meet language and symptom-related criteria. The study includes follow-up through clinical appointments and data collection from up to 920 women total.

Researchers are studying treatments for Post-Traumatic Stress Disorder PTSD and traumatic brain injury TBI with associated headaches, which are common injuries in military personnel from various conflicts. The trial aims to evaluate whether a procedural intervention called stellate ganglion block SGB, medication ketamine, or their combination can reduce symptoms of PTSD and TBI-related headaches. This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to compare the effectiveness of these treatments and explore factors linked to treatment success. Participants will be randomly assigned to one of four groups SGB with bupivacaine plus placebo ketamine, sham SGB plus ketamine infusion, SGB plus ketamine infusion, or sham SGB plus placebo ketamine. The SGB is performed using ultrasound or fluoroscopic guidance, and ketamine or placebo is given via infusion and boluses over 30 to 60 minutes. Treatments are administered once, followed by regular assessments at 1, 2, 4, 8, and 12 weeks, with unblinding and longer follow-up at 6 and 12 months for those showing positive outcomes. During the study, participants will complete various questionnaires and assessments about headache impact, PTSD symptoms, pain levels, quality of life, anxiety, depression, and medication use. Those who respond positively continue in the trial with ongoing evaluations, while those who do not respond exit the trial but may receive other treatments as determined by their providers. Researchers will also explore brain imaging and biomarker changes in some participants to understand treatment effects better. The total participation can last up to one year for some individuals based on their response.

Researchers are evaluating the effectiveness of a new ankle rehabilitation program called NATION for physically active individuals with chronic ankle instability CAI. CAI often follows repeated ankle sprains and causes ongoing pain, instability, and difficulty with physical activity. This study aims to compare the NATION program, which includes neurocognitive exercises, against a standard evidence-based rehabilitation and a no-treatment control group to see if it improves clinical health outcomes, reduces injuries, and helps maintain active duty status in military and civilian participants. The study has three groups the NATION intervention group, an evidence-based rehabilitation group without neurocognitive exercises, and a control group continuing their normal routine. Both rehabilitation groups undergo a 6-week program with up to 18 unsupervised home sessions and 12 supervised sessions that include exercises for range of motion, strength, balance, and ankle care. The NATION group adds neurocognitive tasks to address brain function alongside physical rehabilitation. The control group does not receive these interventions. Participants will be assessed at the start, after 6 weeks, and at 6 months for clinical measures like ankle strength, balance, motor cognition, range of motion, and sensation. They will also complete questionnaires about pain, function, fear, quality of life, and injury history. Active-duty service members will report on their confidence to deploy. Medical records will be checked for surgery related to CAI for up to 5 years. Participant workload during therapy and satisfaction with the programs will also be measured. The total participation involves supervised sessions over 6 weeks and follow-ups extending to several months and years for surgical outcomes.

Musculoskeletal injuries MSKI and traumatic brain injury TBI, especially concussions, are common and serious issues affecting military Service Members and physically active civilians. This research aims to identify how neuromuscular control changes after concussion may increase the risk of MSKI. The study will compare individuals who have had a concussion with those who have not, to understand the reasons behind this increased injury risk and help develop targeted prevention strategies. Participants will undergo detailed assessments including dynamic movement tests like jump-landing, single leg hop, anticipated cut, and gait tasks, along with strength and muscle activation tests. Sensory evaluations will assess proprioception and light touch sensation. These assessments occur at three time points within 5 days of becoming asymptomatic post-concussion, then at 6 and 12 weeks after the initial assessment. Both concussed and matched non-concussed participants will complete the same testing and self-report psychosocial measures. During the study, participants will report any new musculoskeletal injuries and complete monthly questionnaires for about one year. Researchers will track changes in movement, muscle function, sensory abilities, and patient-reported outcomes over time. The study also monitors psychological factors such as anxiety, depression, and pain interference. This comprehensive approach will help measure how neuromuscular control evolves after concussion and its connection to injury risk.

Researchers are evaluating the effects and safety of erenumab, a calcitonin gene-related peptide cGRP monoclonal antibody, compared to placebo for treating acute posttraumatic headache PTH in both military service members and civilians who have experienced mild traumatic brain injury mTBI. The study is designed to explore preventive treatment based on the idea that posttrauma headache resembles migraine and involves activation of the trigeminal vascular system and cGRP release. This is a randomized, double-blind, placebo-controlled Phase 2 study conducted at military treatment facilities across the United States. Participants receive either erenumab 140 mg or placebo via subcutaneous injections. The active drug is administered as two 70-mg injections once monthly at three time points over a 12-week period. The placebo group receives two subcutaneous injections on the same schedule. After the 12-week treatment phase, there is a 4-week open-label safety extension where all participants are monitored. During the study, participants will be monitored for headache frequency and safety from week 0 to week 12, with the primary outcome measuring monthly headache days between weeks 8 and 12. Secondary outcomes include headache days over various intervals, adverse events, return to full duty status, medication use, physical impairment, and assessments of headache impact, depression, and insomnia. Participants must be able to provide informed consent and have access to standard care for PTH and TBI. The total participation duration includes treatment and safety monitoring over approximately 16 weeks.