The Effects of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training in Patients With TBI

Study Overview
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Brief Summary
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Long-term sequelae in TBI is a well-recognized burn. We designed a proof of concept study, randomized, double-blind, placebo-controlled to evaluate 36 adult TBI patients. To evaluate the early and late effects of 10 days of 20 minutes applying transcranial direct-current stimulation (tDCS) in the dorsolateral prefrontal cortex (DLPFC), bilateral temporal cortex (CTB) and compare to sham stimulation, and online cognitive training. We expect that the active group will differ from the sham group, showing larger effect sizes in the cognitive assessment.

Detailed Description
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Method: proof of concept study, randomized, double-blind, placebo-controlled. 36 adult patients will be recruited, with closed TBI for at least 6 months, of both sexes. The sequence of randomization will provide the allocation 1: 1: 1 in parallel groups: G1 n = 12 active (CTB), G2 n = 12 active (DLPFC), and G3 n = 12 (Sham). The tDCS will be held with the intensity of 2 mA for 20 minutes per session and online cognitive training (concurrent with the ETCC). All patients, after the screening and randomization, will make a baseline neuropsychological assessment (T0) and receive 10 sessions of stimulation concomitant to cognitive training. Patients will undergo neuropsychological reassessment one week (T1) and two months (T2) after the last tDCS session. We will evaluate performance on episodic memory tests, working memory and attention in the three periods (T0, T1, and T2). The significance adopted is the level of 5% (α = 0.05), analysis of 80% power and bicaudal curve. Analysis of the results will be done by intention to treat (ITT).

Official Title
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The Effects of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training on Episodic Memory and Attention in Patients With Traumatic Brain Injury: a Double-blind, Randomized, Placebo-controlled Study

Conditions
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Traumatic Brain Injury, Closed Traumatic Brain Injury, Severe Brain Injury

Intervention / Treatment
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* Device: Transcranial direct current stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis closed traumatic brain injury, cognitive complaints reported by the patient or caregiver. Exclusion Criteria: metal implants in the head, seizures, abnormal EEG, depressive symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 - G1<br>bitemporal anodal stimulation and cathodal stimulation at supraorbital region. | Device: Transcranial direct current stimulation (tDCS)<br>* 10 sessions of 2mA and 20 minutes tDCS. Sponges size 5x7 cm. For the sham condition, the patient will receive just 30 seconds of stimulation.<br>|
| Active Comparator: Group 2 - G2<br>dorsolateral prefrontal anodal stimulation and cathodal stimulation at contralateral supraorbital region. | Device: Transcranial direct current stimulation (tDCS)<br>* 10 sessions of 2mA and 20 minutes tDCS. Sponges size 5x7 cm. For the sham condition, the patient will receive just 30 seconds of stimulation.<br>|
| Sham Comparator: Group 3 - G3<br>sham anodal stimulation over bitemporal or dorsolateral prefrontal cortex (randomized) and sham cathodal over the orbitofrontal region. | Device: Transcranial direct current stimulation (tDCS)<br>* 10 sessions of 2mA and 20 minutes tDCS. Sponges size 5x7 cm. For the sham condition, the patient will receive just 30 seconds of stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT) | List of words | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory cognitive training | The patients will receive 10 days of episodic memory training. | up to 2 weeks | 
| Attention cognitive training | The patients will receive 10 days of attention training. | up to 2 weeks |