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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, double-blind, randomized, parallel, controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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tDCS plus Computer-assisted training

Patients will receive 10 sessions of active anodal tDCS on the left prefrontal cortex dorsolateral (F3 area using International 10-20 system for electroencephalogram (EEG) electrode placement) plus Computer-assisted cognitive training (games to improve working memory, attention, and executive function).

Group Type ACTIVE_COMPARATOR

anodal tDCS

Intervention Type DEVICE

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.

Computer-assisted training

Intervention Type DEVICE

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.

tDCS sham plus Computer-assisted training

Patients will receive 10 sessions of sham anodal tDCS on the left prefrontal cortex dorsolateral plus Computer-assisted cognitive training (games to improve working memory, attention and executive function).

Group Type SHAM_COMPARATOR

Computer-assisted training

Intervention Type DEVICE

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.

sham tDCS

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Chronic TBI (≥ 12 months)
* Severe TBI (Glasgow ≤ 8, loss of consciousness \> 24 hours, post-traumatic amnesia \> 1 week)
* Working memory, attention or executive deficit
* Score in Mini Mental State Examination according the cut-off point (i.e, 13 to illiterates individuals, 18 to low and medium schooling and 26 to high schooling).

Exclusion Criteria

* Individuals unable to perform the activities proposed in the study protocol (e.g. physical deficits, lack of collaboration, aphasia, accuses, amaurosis)
* Mid or extensive cranial defects
* Titanium cranial prosthesis
* Extensive cranial prosthesis located on the dorsal prefrontal cortex
* Metallic devices implanted in the brain
* Psychotic disorders
* Recent history of alcoholism or use of drugs
* Neurological diseases (e.g Parkinson, Stroke, Alzheimer).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No