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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04540783
• Other study ID #: 2241648
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2020
• Source: University of Sao Paulo General Hospital
• Contact: Wellingson S Paiva, MD PhD
• Phone: +5511975992245
• Email: wellingsonpaiva[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Closed Traumatic Brain Injury
• Severe Brain Injury
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do Hospital das Clinicas HC-FMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	electroencephalogram - EEG	electroencephalogram will be used for safety (Alpha and delta wave)	up to 2 weeks
Primary	Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT)	List of words	up to 2 weeks
Secondary	Memory cognitive training	The patients will receive 10 days of episodic memory training.	up to 2 weeks
Secondary	Attention cognitive training	The patients will receive 10 days of attention training.	up to 2 weeks