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

Not Applicable

• Conditions: Traumatic Brain Injury; Closed Traumatic Brain Injury; Severe Brain Injury
• Interventions: Device: Transcranial direct current stimulation (tDCS)

• Registration Number: NCT04540783
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2020-03-09
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Study Start: 2020-09-01
• Study First Posted: 2020-09-07
• Last Update Posted: 2020-09-07
• Primary Completion: 2021-06-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - G1	Transcranial direct current stimulation (tDCS)	bitemporal anodal stimulation and cathodal stimulation at supraorbital region.
Group 2 - G2	Transcranial direct current stimulation (tDCS)	dorsolateral prefrontal anodal stimulation and cathodal stimulation at contralateral supraorbital region.
Group 3 - G3	Transcranial direct current stimulation (tDCS)	sham anodal stimulation over bitemporal or dorsolateral prefrontal cortex (randomized) and sham cathodal over the orbitofrontal region.

Primary Outcome Measures

Name	Time	Method
Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT)	up to 2 weeks	List of words

Secondary Outcome Measures

Name	Time	Method
Memory cognitive training	up to 2 weeks	The patients will receive 10 days of episodic memory training.
Attention cognitive training	up to 2 weeks	The patients will receive 10 days of attention training.

Trial Locations

Locations (1)

Faculdade de Medicina do Hospital das Clinicas HC-FMUSP; 🇧🇷 São Paulo, SP, Brazil