Safety and Feasibility of Low-Intensity Focused Ultrasound Neuromodulation Using the Next Generation Dome Helmet in Disorders of Consciousness

What this Trial Is About

Researchers are investigating the safety and feasibility of low-intensity focused ultrasound FUS neuromodulation delivered to the bilateral central thalamus in patients with disorders of consciousness due to severe brain injury. This pilot clinical trial aims to determine whether this treatment can be safely administered and if it results in short-term improvements in arousal or behavioral responsiveness. The study also evaluates changes in brain activity using EEG and functional MRI. Participants will receive two sessions of MRI-guided low-intensity FUS neuromodulation using the Next Generation Dome Helmet NGDH, targeting specific thalamic nuclei. These sessions are spaced approximately four weeks apart. Continuous safety monitoring occurs during each treatment. Imaging and clinical assessments, including EEG, MRI, and standardized clinical scales such as the Coma Recovery Scale-Revised and Glasgow Coma Scale, are performed before and after treatments. Throughout the study, participants undergo thorough evaluations including planning CT scans, baseline and follow-up MRIfMRI, EEG monitoring, and clinical assessments at multiple time points before treatment, two weeks after each treatment, twelve weeks after the second treatment, and at one year post-injury when possible. The research team tracks feasibility, safety, behavioral responsiveness, neural activity changes, and clinical outcomes over the course of these follow-ups.

Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Disorders of Consciousness