Clinical trial Recruiting at 1 site Phase 2 Interventional

Noninvasive neuromodulation for people with traumatic brain injury and healthy volunteers

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

Run by University of Sao Paulo · NCT07373366 · Data updated 2026-11-12

We will try a noninvasive radioelectric neuromodulation (REAC) treatment to see if it changes brain waves in people with diffuse axonal injury after severe TBI and in healthy volunteers.

More Traumatic Brain Injury trials

Quick facts

PhasePhase 2
Study typeInterventional
SexAll
Enrollment60 (estimated)
SponsorUniversity of Sao Paulo
Academic / other
Locations1 site (São Paulo, São Paulo)
StatusRecruiting
StartedApril 1, 2025
Main results expectedDecember 2026
Study endsMay 2027
Registry record updatedJanuary 28, 2026
Trial IDNCT07373366 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with a confirmed diagnosis of diffuse axonal injury after severe TBI who are medically stable after ICU discharge and whose next of kin can provide consent, excluding those with open head injuries or chronic neurological disorders.

Probably not a fit

Patients with open traumatic brain injuries, preexisting chronic neurological conditions, or who remain medically unstable after ICU discharge are unlikely to benefit or to be eligible for this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-blind Phase 2 trial, patients with diffuse axonal injury and healthy volunteers are assigned to active or sham REAC after ICU discharge. The intervention includes one Neuro Postural Optimization session followed by up to 18 NPPO-BWO-G sessions (maximum four per day), for a total of 19 sessions. Quantitative EEG (qEEG) and population brain electrical mapping will measure cerebral electrical activity before and after the protocol. The trial compares qEEG pattern changes between active and sham groups to determine whether REAC alters brain wave activity.

Why it matters

Potential benefit: If successful, REAC could help normalize disrupted brain electrical patterns after diffuse axonal injury and potentially improve neurological recovery and function.

How similar studies have gone: Other noninvasive neuromodulation methods such as TMS and tDCS have shown some promise in modulating brain activity after TBI, but REAC is a newer and less-studied technique with limited prior clinical evidence.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.