Clinical trial NCT03382626: Transcranial Direct Current Stimulation and Computer-based Training for the Traumatic Brain Injury Rehabilitation
Official title: Transcranial Direct Current Stimulation and Computer-based Training for the Rehabilitation of Cognitive Function in Traumatic Brain Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Transcranial Direct Current Stimulation
Computer-assisted training
Cognitive training
Cognitive function
Executive function
Working memory
Attention
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, double-blind, randomized, parallel, controlled study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline working memory at 10 days of intervention (scale assessment)
timeFrame: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, i.e 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
measure: Change from baseline working memory at 10 days of intervention (computer-based assessment)
timeFrame: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
measure: Change from baseline executive function at 10 days of intervention (scale assessment)
timeFrame: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
measure: Change from baseline attention and executive function at 10 days of intervention (scale assessment)
timeFrame: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
measure: Change from baseline processing speed at 10 days of intervention (scale assessment)
timeFrame: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Secondary outcomes:
measure: Change from baseline processing speed at 10 days of intervention (computer-based assessment)
timeFrame: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
measure: Change from baseline reasoning and planning at 10 days of intervention (computer-based assessment)
timeFrame: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
measure: Change from baseline quality of life at 10 days of intervention
timeFrame: We will apply the QOLIBRI at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
measure: Change from baseline depression at 10 days of intervention
timeFrame: We will apply the BDI at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and and T3 (i.e after 1 month of follow-up time).
Other outcomes:
measure: Adverse effects assessment
timeFrame: We will apply the AEQ at end of each sessions of anodal tDCS (i.e one by day during 10 days)
measure: Sociodemographic and Neurological assessment
timeFrame: We will apply this questionnaire only at T0 (baseline time)
measure: Mental state examination assessment
timeFrame: We will apply this questionnaire only at T0 (baseline time)
Locations:
city: São Paulo
country: Brazil
facility: Ambulatório de Reabilitação Cognitiva do Hospital das Clínicas da Universidade de São Paulo
Study officials:
References: