NCT07373366 Assessment of Noninvasive Neuromodulation in a Group of Traumatic Brain Injured Patients and Healthy Volunteers
| NCT ID | NCT07373366 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Sao Paulo |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-04-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07373366 clinical trial?
This trial is open to participants of all sexes, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07373366 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07373366 currently recruiting?
Yes, NCT07373366 is actively recruiting participants. Contact the research team at sbrasil@alumni.usp.br for enrollment information.
Where is the NCT07373366 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07373366 clinical trial?
NCT07373366 is sponsored by University of Sao Paulo. The trial plans to enroll 60 participants.