NCT04540783

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Traumatic Brain Injury
• Closed Traumatic Brain Injury
• Severe Brain Injury

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation (tDCS)	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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-06-01
• Completion: 2022-12-01
• First posted: 2020-09-07
• Last updated: 2020-09-07

Locations

1 site across 1 country: Brazil