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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Traumatic Brain Injury

Treatments: Device: anodal tDCS; Device: sham tDCS; Device: Computer-assisted training

Study type: Interventional

Funder types: Other

Identifiers

NCT03382626

71391917000000068

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups

tDCS plus Computer-assisted training

Active Comparator group

Description:

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).

Treatment:

Device: Computer-assisted training

Device: anodal tDCS

tDCS sham plus Computer-assisted training

Sham Comparator group

Description:

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).

Treatment:

Device: Computer-assisted training

Device: sham tDCS