Effects of transcranial direct current stimulation (tDCS) and concurrent cognitive training on episodic memory in patients with traumatic brain injury: a double-blind, randomised, placebo-controlled study

Daglie Jorge De Freitas, Daniel De Carvalho, Vanessa Maria Paglioni, Andre R Brunoni, Leandro Valiengo, Maria Sigride Thome-Souza, Vinícius M P Guirado, Ana Luiza Zaninotto, Wellingson S Paiva, Daglie Jorge De Freitas, Daniel De Carvalho, Vanessa Maria Paglioni, Andre R Brunoni, Leandro Valiengo, Maria Sigride Thome-Souza, Vinícius M P Guirado, Ana Luiza Zaninotto, Wellingson S Paiva

Abstract

Introduction: Deficits in episodic memory following traumatic brain injury (TBI) are common and affect independence in activities of daily living. Transcranial direct current stimulation (tDCS) and concurrent cognitive training may contribute to improve episodic memory in patients with TBI. Although previous studies have shown the potential of tDCS to improve cognition, the benefits of the tDCS applied simultaneously to cognitive training in participants with neurological disorders are inconsistent. This study aims to (1) investigate whether active tDCS combined with computer-assisted cognitive training enhances episodic memory compared with sham tDCS; (2) compare the differences between active tDCS applied over the left dorsolateral prefrontal cortex (lDLPFC) and bilateral temporal cortex (BTC) on episodic memory and; (3) investigate inter and intragroup changes on cortical activity measured by quantitative electroencephalogram (qEEG).

Methods and analysis: A randomised, parallel-group, double-blind placebo-controlled study is conducted. Thirty-six participants with chronic, moderate and severe closed TBI are being recruited and randomised into three groups (1:1:1) based on the placement of tDCS sponges and electrode activation (active or sham). TDCS is applied for 10 consecutive days for 20 min, combined with a computer-based cognitive training. Cognitive scores and qEEG are collected at baseline, on the last day of the stimulation session, and 3 months after the last tDCS session. We hypothesise that (1) the active tDCS group will improve episodic memory scores compared with the sham group; (2) differences on episodic memory scores will be shown between active BTC and lDLPFC and; (3) there will be significant delta reduction and an increase in alpha waves close to the location of the active electrodes compared with the sham group.

Ethics and dissemination: This study was approved by Hospital das Clínicas, University of São Paulo Ethical Institutional Review Border (CAAE: 87954518.0.0000.0068).

Trial registration number: NCT04540783.

Keywords: clinical trials; neurological injury; rehabilitation medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
CONSORT flow diagram. BTC, bilateral temporal cortex; CONSORT, Consolidated Standards of Reporting Trials; DLPFC, dorsolateral prefrontal cortex.

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