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Transcranial Direct Current Stimulation and Computer-based Training for the Traumatic Brain Injury Rehabilitation

NCT03382626 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-05

No results posted yet for this study

Summary

Traumatic Brain Injury (TBI) is a serious public health problem due to its high mortality and morbidity rates, mainly affecting young adult males. Aggression to the prefrontal cortex, caused by an external physical force, responsible for anatomical injury and/or functional impairment, causes cognitive deficits with important consequences for the individual affected by the trauma and their caregivers. Therefore, rehabilitation is of utmost importance. The increase in pre-frontal cortical activation through training, activity-dependent stimulation and neuroplasticity, especially in the dorsolateral prefrontal cortex (DLPFC) is related to better performance in functional memory. In this context, Transcranial Direct Current Stimulation (tDCS), intended to drive neuroplastic changes in the brain, has been widely used to bring benefits to the cognitive function of individuals affected by various neurological conditions, including TBI by promoting neuroplasticity for critically involved cortical areas in the performance of tasks, culminating in cognitive benefits. In addition, studies have shown greater benefits when the technique is combined with cognitive training. Therefore, the objective of this parallel, randomized, double-blind, placebo-controlled clinical trial is to investigate the effect of tDCS applied on the dorsolateral prefrontal cortex and virtual reality cognitive training alone or in association with tDCS on cognitive function of individuals with severe chronic TBI.

Conditions

Interventions

DEVICE

anodal tDCS

Anodal tDCS will be applied on the left prefrontal cortex dorsolateral (F3 area using International 10-20 system for EEG electrode placement) with the following parameters: electrode size of 25-35 cm², 2mA, 0.057 mA/cm² and duration of 20 minutes. The cathode will be placed over the supra-orbital region.

DEVICE

Computer-assisted training

The computer-assisted cognitive training will consist of games with visual and auditory stimuli to improve working memory, attention, and executive function. The games will be Genius and Labyrinth games, reaction time and timing-coincident.

DEVICE

sham tDCS

Sham tDCS will be applied with the same parameters and electrode placement of active anodal tDCS. However, the current flow will be interrupted by the device after few seconds.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2018-11-30
Completion
2019-10-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03382626 on ClinicalTrials.gov