Noninvasive neuromodulation for people with traumatic brain injury and healthy volunteers
Effects of Neurobiological Therapy With Asymmetric Radio-electric Conveyer (REAC) in Diffuse Axonal Injury: a Randomized Controlled Trial.
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07373366 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
São Paulo, São Paulo
- Hospital das Clínicas da FM-USP — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Sérgio Brasil, MD. PhD.
- Email: sbrasil@alumni.usp.br
- Phone: +5511981210990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.