South Charleston

Researchers are evaluating the effects of ALTO-207 on adults with treatment-resistant depression (TRD). This Phase 2 trial compares ALTO-207 against a placebo to measure changes in depressive symptoms in participants who have moderate to severe major depressive disorder and have not responded adequately to previous antidepressant treatments. The goal is to understand how well ALTO-207 works in improving depression symptoms in this group. Participants will receive either ALTO-207 twice daily or a matching placebo. This randomized, double-blind, placebo-controlled trial involves treatment over a period of up to 8 weeks, during which symptom changes will be closely monitored. The study focuses on adults aged 18 to 75 who are already on stable doses of one or two oral antidepressants. During the study, participants will be assessed for changes in their depression severity using the MADRS (Montgomery-Åsberg Depression Rating Scale) from baseline up to 8 weeks. Researchers will monitor safety and symptom changes throughout the treatment period. Participants’ adherence to the treatment and overall health will also be observed to gather comprehensive data on the study outcomes.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) device for treating moderate to severe Alcohol Use Disorder (AUD) in adults aged 18 to 86 years. This is a prospective, double-blind, randomized, controlled trial conducted over 6 months at multiple academic and private research centers. The study compares active Deep TMS treatment to a sham (inactive) treatment to assess their impacts on alcohol use, specifically focusing on reducing heavy drinking days. Participants are randomly assigned to receive either the Deep TMS treatment or the sham treatment in a 1:1 ratio. The acute treatment phase lasts 3 to 5 weeks with 15 visits, each including two treatment sessions per visit spaced 30 minutes apart. Following this, there is a maintenance and follow-up phase with one treatment session per week until the 6-month follow-up visit. During each treatment session, participants are exposed to alcohol-related cues before receiving either active or sham Deep TMS stimulation. Throughout the study, participants undergo various assessments including surveys on alcohol consumption and craving, physical and neurological exams, and safety monitoring for adverse events and vital signs. The main outcome measured is the proportion of participants who achieve zero heavy drinking days between months 2 and 4. The total study duration for participants is approximately 6 months, including initial screening, treatment, maintenance, and follow-up evaluations.