Safety and Feasibility Study of Low-Intensity Transcranial Ultrasound Stimulation for Treating Schizophrenia in Adults

What this Trial Is About

Researchers are evaluating the safety and feasibility of transcranial ultrasound stimulation TUS as a treatment for individuals diagnosed with schizophrenia. This study focuses on using non-invasive, low-intensity pulsed ultrasound targeting the hippocampus and surrounding brain areas. The primary goal is to assess safety, while a secondary goal is to explore whether the treatment parameters may improve symptoms and support future use to enhance patients daily life quality. Participants will receive either the actual TUS treatment or a placebo version without real stimulation, in a randomized and triple-masked study design. The treatment involves device-based stimulation sessions directed at specific brain areas. The study includes a screening phase 4 weeks before treatment, followed by treatment and observation periods extending through Week 134 weeks. Throughout the study, participants undergo evaluations including electrocardiograms ECG, blood tests measuring brain-related factors like BDNF and various interleukins, neurological exams, and vital signs monitoring. Psychiatric symptoms, depression levels, and cognitive function are assessed at multiple timepoints. Safety and symptom changes are tracked up to Week 134 weeks, ensuring thorough monitoring of participant health and response. Total participation spans several months from screening through follow-up visits.

Exploring the Feasibility of Transcranial Ultrasound Stimulation in the Treatment of Schizophrenia