Actively Recruiting

Phase 2
All Genders
Healthy Volunteers
ID07373366

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

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

60

Participants Needed

1

Research Sites

21 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

Researchers are evaluating the effects of a noninvasive neuromodulation technique called the radio electric asymmetric conveyer (REAC) in patients with diffuse axonal injury (DAI), a severe form of traumatic brain injury (TBI) that often leads to long-lasting neurological problems. This study aims to assess changes in brain electrical activity patterns using quantitative electroencephalography (qEEG) after REAC treatment. The trial is a randomized, double-blind clinical study focusing on patients after intensive care unit discharge. Participants will be assigned to either an active treatment group receiving REAC therapy or a sham group undergoing simulated therapy. The active intervention includes one session of Neuro Postural Optimization and up to 18 sessions of Brain Wave Optimization (NPPO-BWO-G), with up to four sessions per day. The study also includes healthy volunteers to compare brain wave changes following REAC neuromodulation. During the study, researchers will monitor changes in qEEG patterns and evaluate clinical outcomes using the modified Rankin scale and Glasgow outcome scale over a six-month period. The study involves multiple assessments to observe neurological and cognitive changes, with safety and efficacy tracked through these measures. The total participation time includes treatment sessions and follow-up evaluations extending to six months after intervention.

CONDITIONS

Brief 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...

  • Diagnosis of diffuse axonal injury (DAI)
  • Consent for participation provided 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of treatment sessions as per protocol (18 sessions plus 1 session for neuro-postural optimization)

Participants receive either active low-frequency radioelectric therapy or a sham therapy using the device. The active therapy includes one neuro-postural optimization session followed by 18 brain-wave optimization sessions.

Multiple visits corresponding to the 19 therapy sessions

Follow-up

Duration - Up to 6 months

Participants are monitored for clinical and electroencephalographic changes for up to six months after treatment completion.

Periodic visits during the 6-month follow-up

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.

A

Alessandra C Renck, MD. PhD.

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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https://pubmed.ncbi.nlm.nih.gov/25011544

Does osteoarthritis of the knee also have a psychogenic component? Psycho-emotional treatment with a radio-electric device vs. intra-articular injection of sodium hyaluronate: an open-label, naturalistic study.

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Visuospatial memory improvement in patients with diffuse axonal injury (DAI): a 1-year follow-up study.

Ana Luiza Zaninotto, Jessica Elias Vicentini, Davi Jorge Fontoura Solla...

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Improving Functional Capacity and Quality of Life in Parkinson's Disease Patients through REAC Neuromodulation Treatments for Mood and Behavioral Disorders.

Chiara Rinaldi, Cleuton Braga Landre, Maria Izabel Volpe...

https://pubmed.ncbi.nlm.nih.gov/37373926

Neuro Postural Optimization Neuromodulation Treatment of Radio Electric Asymmetric Conveyer Technology on Stress and Quality of Life in Institutionalized Children in a Capital City of the Brazilian Amazon.

Ana V Gonçalves de Oliveira Cruz, Rebeca Góes Gonçalves, Lucas Nunes...

https://pubmed.ncbi.nlm.nih.gov/35815301

REAC Cervicobrachial Neuromodulation Treatment of Depression, Anxiety, and Stress During the COVID-19 Pandemic.

Ana Rita Pinheiro Barcessat, Marina Nolli Bittencourt, Larissa Duarte Ferreira...

https://pubmed.ncbi.nlm.nih.gov/33204186