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

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

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.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury; Severe Brain Injury; Closed Traumatic Brain Injury
• Intervention / Treatment: Device: Transcranial direct current stimulation (tDCS)

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-000
      • Recruiting
      • Faculdade de Medicina do Hospital das Clinicas HC-FMUSP
      • Contact: Vanessa M Paglioni, BA; Phone Number: +5511995071977; Email: vanessapaglioni@gmail.com
      • Contact: Daniel deCarvalho, BA; Phone Number: +5511972594210; Email: daniel_carvalho78@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT)	List of words	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory cognitive training	The patients will receive 10 days of episodic memory training.	up to 2 weeks
Attention cognitive training	The patients will receive 10 days of attention training.	up to 2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
electroencephalogram - EEG	electroencephalogram will be used for safety (Alpha and delta wave)	up to 2 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Welligson S Paiva, MD PhD, Professor

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 2241648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We need to discuss between the researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No