Clinical Research Directory

Temporal Interference Stimulation for Disorders of Consciousness

This study aims to investigate whether a new non-invasive brain stimulation technique, called temporal interference stimulation, can influence brain activity and potentially improve signs of consciousness in patients with severe brain injuries and disorders of consciousness. After a severe brain injury, some patients may remain unable to communicate or interact normally with their environment because of impaired consciousness. Current treatment options to promote recovery are limited. Temporal interference stimulation is a new technique that uses mild electrical currents applied through electrodes placed on the scalp to target specific areas deep inside the brain without surgery. In this study, we will use brain imaging data to personalize the stimulation and target a region involved in consciousness regulation, called the thalamus. The effects of the stimulation will be evaluated using brain activity recordings, heart monitoring, and clinical assessments of consciousness and responses to stimulation. The goal of this research is to determine whether temporal interference stimulation is safe and whether it can produce measurable changes in brain function and behavior in patients with disorders of consciousness. The results may help guide future research on new treatments for recovery after severe brain injury.

AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness

Disorders of consciousness (DoC) are severe neurological conditions characterized by impaired awareness and reduced interaction with the environment. Although hyperbaric oxygen therapy (HBOT) may promote neurological recovery, the optimal treatment strategy for individual patients remains unclear. This study aims to develop and validate an artificial intelligence-assisted precision decision support system for HBOT based on dynamic BIS-EEG brain functional feedback. The system will integrate clinical information, neuroimaging data, physiological parameters, consciousness assessments, and HBOT treatment characteristics. Continuous BIS-EEG monitoring will be performed during different phases of HBOT, including compression, oxygen exposure, air breaks, decompression, and post-treatment recovery. Artificial intelligence models will analyze these dynamic brain functional responses to predict treatment effectiveness and support personalized HBOT management. The primary outcome will be improvement in consciousness assessed by the Coma Recovery Scale-Revised (CRS-R). Secondary outcomes include changes in consciousness state, cognitive and functional recovery, and treatment-related adverse events.

Prognostication of Recovery in Early Disorders of Consciousness Study

The goal of this study is to determine the extent to which neuroimaging metrics (e.g., functional MRI) are associated with the current level of consciousness, and future consciousness recovery, in patients with disorders of consciousness resulting from acute brain injury. The main questions this study aims to answer are: How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with current level of consciousness? How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with future recovery of consciousness? How does noxious stimulation affect the detection of covert consciousness and functional brain network connectivity?

Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness

Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders of consciousness. Notably, a case reported improvement of level of consciousness using transcutaneous auricular vagal nerve stimulation in a patient in unresponsive wakefulness syndrome. Here we aim to assess the effects of transcutaneous auricular vagal nerve stimulation on post-coma patients with disorders of consciousness in a first randomized controlled trial. To measure these effects, behavioral (Coma recovery scale revised - CRS-R -primary outcome) and neuro-electrophysiological (electroencephalography - EEG - secondary outcome) data will be recorded in severely brain-injured patients with DOC.

Effectiveness of tTIs for Improving Consciousness in Patients With DoC

The goal of this clinical trial is to learn if a new type of brain stimulation called theta-burst patterned temporal interference stimulation (tTIs) works to improve awareness in people with disorders of consciousness (DoC). The main questions it aims to answer are: 1. Does tTIs help people with disorders of consciousness show more signs of awareness? 2. Does tTIs improve the brain's ability to process information and connect different brain areas? Is tTIs safe and easy for people with disorders of consciousness to tolerate? Researchers will compare a group receiving active tTIs to a group receiving a "sham" stimulation (a look-alike stimulation that delivers no real current) to see if the real stimulation works better. Participants will:Receive either active tTIs or sham stimulation twice a day for 5 consecutive days (total of 10 sessions). Undergo brain activity tests (EEG) and physical exams to check their level of awareness before and after the 5 days of treatment. Have their progress followed by researchers through phone calls at 1, 3, and 6 months after the treatment ends.