Wearable Neural Interfacing System for REM Sleep Restoration and Enhancement

"The NEUSleeP system is a wearable FUS-EEG device integrating hydrogel-based EEG and focused ultrasound neuromodulation. The intervention includes:~1. Device testing in 4 healthy volunteers to assess EEG signal and impedance over 4 weeks vs. wet electrodes;~2. STN targeting validation in up to 20 participants using MRI-guided tFUS with NEUSleeP and BrainSonix Pulsar 1002, with fMRI analysis of BOLD activation in stress-related areas (amygdala, insula);~3. REM sleep modulation in 16 healthy participants across two nights, evaluating REM sleep architecture and stress-related fMRI changes following STN stimulation during REM;~4. A similar protocol in 12 individuals with self-reported poor sleep and moderate stress, assessing subjective stress (PSS), sleep dynamics, and connectivity changes post-tFUS."

The BrainSonix Pulsar 1002 is a research-grade focused ultrasound device used to evaluate STN targeting in up to 20 healthy participants. COMSOL 2D acoustic simulations and structural MRI are used to localize the STN. The BrainSonix system is tuned and installed for STN stimulation during fMRI scanning. Pre- and post-stimulation fMRI is conducted to verify BOLD signal changes in the STN and related regions. These responses are compared with those from NEUSleeP stimulation, using identical imaging protocols. Ultrasound parameters are iteratively adjusted to optimize targeting while adhering to FDA diagnostic ultrasound safety limits. A linear mixed model is used to assess stimulation-induced changes.