Clinical trial NCT04540783: The Effects of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training in Patients With TBI
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Closed Traumatic Brain Injury
Severe Brain Injury
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT)
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Memory cognitive training
timeFrame: up to 2 weeks
measure: Attention cognitive training
timeFrame: up to 2 weeks
Other outcomes:
measure: electroencephalogram - EEG
timeFrame: up to 2 weeks
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina do Hospital das Clinicas HC-FMUSP
state: SP
Study officials:
affiliation: professor
name: Welligson S Paiva, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Freitas DJ, De Carvalho D, Paglioni VM, Brunoni AR, Valiengo L, Thome-Souza MS, Guirado VMP, Zaninotto AL, Paiva WS. 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. BMJ Open. 2021 Aug 26;11(8):e045285. doi: 10.1136/bmjopen-2020-045285.