Actively Recruiting

Phase 2
All Genders
Healthy Volunteers
NCT07373366

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

Led by University of Sao Paulo · Updated on 2026-01-28

60

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

Sponsors

U

University of Sao Paulo

Lead Sponsor

I

Istituto Rinaldi Fontana

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with diffuse axonal injury (DAI)
  • Consent for participation given by next of kin for each eligible patient
Not Eligible

You will not qualify if you...

  • Open traumatic brain injury (TBI)
  • History of chronic neurological conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital das Clínicas da FM-USP

São Paulo, São Paulo, Brazil, 05.403-905

Actively Recruiting

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Research Team

S

Sérgio Brasil, MD. PhD.

CONTACT

A

Alessandra C Renck, MD. PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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