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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Traumatic Brain Injury; Severe Brain Injury; Closed Traumatic Brain Injury

Treatments: Device: Transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04540783

2241648

Details and patient eligibility

About

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.

Full 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).

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Group 1 - G1

Active Comparator group

Description:

bitemporal anodal stimulation and cathodal stimulation at supraorbital region.

Treatment:

Device: Transcranial direct current stimulation (tDCS)

Group 2 - G2

Active Comparator group

Description:

dorsolateral prefrontal anodal stimulation and cathodal stimulation at contralateral supraorbital region.

Treatment:

Device: Transcranial direct current stimulation (tDCS)

Group 3 - G3

Sham Comparator group

Description:

sham anodal stimulation over bitemporal or dorsolateral prefrontal cortex (randomized) and sham cathodal over the orbitofrontal region.

Treatment:

Device: Transcranial direct current stimulation (tDCS)