Clinical Trial

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

Recruiting Phase 2
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Summary
Background: Severe traumatic brain injury, particularly diffuse axonal injury (DAI), often leads to lasting neurological issues. Cerebral dysfunction in DAI can be evaluated by monitoring cerebral electrical activity (CEA) through EEG. The radio electric asymmetric conveyer (REAC) is a noninvasive method designed to rebalance cellular polarity via endogenous bioelectric fields and modulate CEA. This technique may alter CEA, which can be detected using quantitative EEG (qEEG). Objective: To assess qEEG changes following DAI and brain wave alterations after a REAC protocol in this group. Methods: In this prospective, randomized, double-blind clinical trial, DAI patients will be assigned to active or sham groups for 19 sessions of either true or sham REAC following ICU discharge. Interventions include one Neuro Postural Optimization session and 18 NPPO-BWO-G sessions (up to four per day). The main outcome is to evaluate changes in qEEG patterns through population brain electrical mapping after REAC therapies.
Trial Details
NCT Number NCT07373366
Lead Sponsor University of Sao Paulo
Collaborators: Istituto Rinaldi Fontana
Conditions Traumatic Brain Injury
Enrollment 60 participants
Start Date 2025-04-01
Primary Completion 2026-12 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-01-28