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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04540783
Other study ID # 2241648
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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