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

• Sponsor: University of Sao Paulo General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04540783
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury; Closed Traumatic Brain Injury; Severe Brain Injury	Device: Transcranial direct current stimulation (tDCS)	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: sham device (by code)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 - G1 bitemporal anodal stimulation and cathodal stimulation at supraorbital region.	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.
Active Comparator: Group 2 - G2 dorsolateral prefrontal anodal stimulation and cathodal stimulation at contralateral supraorbital region.	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.
Sham Comparator: Group 3 - G3 sham anodal stimulation over bitemporal or dorsolateral prefrontal cortex (randomized) and sham cathodal over the orbitofrontal region.	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.

Outcome Measures

Primary Outcome Measures

1. Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT) [up to 2 weeks]

   List of words

Secondary Outcome Measures

1. Memory cognitive training [up to 2 weeks]

   The patients will receive 10 days of episodic memory training.

2. Attention cognitive training [up to 2 weeks]

   The patients will receive 10 days of attention training.

Other Outcome Measures

1. electroencephalogram - EEG [up to 2 weeks]

   electroencephalogram will be used for safety (Alpha and delta wave)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculdade de Medicina do Hospital das Clinicas HC-FMUSP	São Paulo	SP	Brazil	05403-000

Sponsors and Collaborators

• University of Sao Paulo General Hospital

Investigators

• Principal Investigator: Welligson S Paiva, MD PhD, professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: WELLINGSON SILVA PAIVA, Supervisor, Division of Neurosurgery, University of Sao Paulo General Hospital
• ClinicalTrials.gov Identifier: NCT04540783
• Other Study ID Numbers: 2241648
• First Posted: Sep 7, 2020
• Last Update Posted: Sep 7, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries

Study Results

No Results Posted as of Sep 7, 2020