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RECRUITINGPhase 2INTERVENTIONAL

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

Effects of Neurobiological Therapy With Asymmetric Radio-electric Conveyer (REAC) in Diffuse Axonal Injury: a Randomized Controlled Trial.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - DAI diagnostic and consent for participation with the next of kin for each eligible patient Who Should NOT Join This Trial: - Open TBI - History of chronic neurological conditions Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * DAI diagnostic and consent for participation with the next of kin for each eligible patient Exclusion Criteria: * Open TBI * History of chronic neurological conditions

Treatments Being Tested

DEVICE

Subjects in the intervention group receive low-frequency radioelectric therapy

The intervention is based on two treatment protocols, the neuro-postural optimization in single aplication and brain-waves optimization in 18 sessions. This protocol is exclusive for the present study.

DEVICE

Sham, the device simulates a therapy session

The device simulates a therapy session

Locations (1)

Hospital das Clínicas da FM-USP
São Paulo, São Paulo, Brazil