Randomized Trial of Noninvasive Radio-Electric Therapy Using REAC for Brain Recovery After Diffuse Axonal Injury

What this Trial Is About

Researchers are evaluating the effects of a noninvasive neuromodulation technique called the radio electric asymmetric conveyer REAC in patients with diffuse axonal injury DAI, a severe form of traumatic brain injury TBI that often leads to long-lasting neurological problems. This study aims to assess changes in brain electrical activity patterns using quantitative electroencephalography qEEG after REAC treatment. The trial is a randomized, double-blind clinical study focusing on patients after intensive care unit discharge. Participants will be assigned to either an active treatment group receiving REAC therapy or a sham group undergoing simulated therapy. The active intervention includes one session of Neuro Postural Optimization and up to 18 sessions of Brain Wave Optimization NPPO-BWO-G, with up to four sessions per day. The study also includes healthy volunteers to compare brain wave changes following REAC neuromodulation. During the study, researchers will monitor changes in qEEG patterns and evaluate clinical outcomes using the modified Rankin scale and Glasgow outcome scale over a six-month period. The study involves multiple assessments to observe neurological and cognitive changes, with safety and efficacy tracked through these measures. The total participation time includes treatment sessions and follow-up evaluations extending to six months after intervention.

Assessment of Noninvasive Neuromodulation in a Group of Traumatic Brain Injured Patients and Healthy Volunteers