Cynthiana

Researchers are evaluating a multimodal music therapy intervention called AMUSED to see if it can improve engagement and reduce behavioral symptoms in older adults with severe dementia living in care facilities. This pilot randomized clinical trial aims to test the study design, identify the best outcome measures for behavioral symptoms, and assess if speech can indicate treatment effectiveness. The study compares music therapy with a reading activity to determine which leads to greater improvements in behavior and speech patterns. Participants will join group sessions twice a week for 12 weeks, each lasting 40 minutes between lunch and dinner. The music therapy involves live, participant-preferred music with singing, touch, and rhythmic instrument playing led by a certified music therapist. The comparison group will participate in reading sessions with stories and discussions led by a trained assistant, following the same schedule and structure but without music. Each small group will work consistently with the same therapist or reader throughout the study. During the study, participants will be observed and assessed multiple times for behavioral symptoms, cognition, and speech, including a follow-up four weeks after treatment ends. Researchers will measure changes in dementia-related behaviors and speech patterns to evaluate the intervention's impact. The study focuses on feasibility, outcome measures, and obtaining preliminary data on the lasting effects of the music therapy intervention over a total participation period of 12 weeks plus follow-up.

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.