Long-lasting changes in brain activation induced by a single REAC technology pulse in Wi-Fi bands. Randomized double-blind fMRI qualitative study.
Salvatore Rinaldi, Marco Mura, Alessandro Castagna...
https://pubmed.ncbi.nlm.nih.gov/25011544Actively Recruiting
Led by University of Sao Paulo · Updated on 2026-01-28
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
U
University of Sao Paulo
Lead Sponsor
I
Istituto Rinaldi Fontana
Collaborating Sponsor
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
Assessment of Noninvasive Neuromodulation in a Group of Traumatic Brain Injured Patients and Healthy Volunteers
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Hospital das Clínicas da FM-USP
São Paulo, São Paulo, Brazil, 05.403-905
Actively Recruiting
S
Sérgio Brasil, MD. PhD.
A
Alessandra C Renck, MD. PhD.
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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