Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Diagnosed with diffuse axonal injury (DAI)
- Consent for participation given by next of kin for each eligible patient
You will not qualify if you...
- Open traumatic brain injury (TBI)
- History of chronic neurological conditions
AI-Screening
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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
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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