The Effects of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training in Patients With TBI
NCT04540783 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2020-09-07
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.
Conditions
- Traumatic Brain Injury
- Closed Traumatic Brain Injury
- Severe Brain Injury
Interventions
- 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.
Sponsors & Collaborators
-
University of Sao Paulo General Hospital
lead OTHER
Principal Investigators
-
Welligson S Paiva, MD PhD · professor
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-01
- Primary Completion
- 2021-06-01
- Completion
- 2022-12-01
Countries
- Brazil
Study Locations
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