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

Primary Purpose

Traumatic Brain Injury, Closed Traumatic Brain Injury, Severe Brain Injury

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Transcranial direct current stimulation (tDCS)

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculdade de Medicina do Hospital das Clinicas HC-FMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group 1 - G1

Group 2 - G2

Group 3 - G3

Arm Description

bitemporal anodal stimulation and cathodal stimulation at supraorbital region.

dorsolateral prefrontal anodal stimulation and cathodal stimulation at contralateral supraorbital region.

sham anodal stimulation over bitemporal or dorsolateral prefrontal cortex (randomized) and sham cathodal over the orbitofrontal region.

Outcomes

Primary Outcome Measures

Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT)

List of words

Secondary Outcome Measures

Memory cognitive training

The patients will receive 10 days of episodic memory training.

Attention cognitive training

The patients will receive 10 days of attention training.

Full Information

NCT ID

NCT04540783

First Posted

March 9, 2020

Last Updated

August 31, 2020

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04540783

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury, Closed Traumatic Brain Injury, Severe Brain Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

sham device (by code)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 - G1

Arm Type

Active Comparator

Arm Description

bitemporal anodal stimulation and cathodal stimulation at supraorbital region.

Arm Title

Group 2 - G2

Arm Type

Active Comparator

Arm Description

dorsolateral prefrontal anodal stimulation and cathodal stimulation at contralateral supraorbital region.

Arm Title

Group 3 - G3

Arm Type

Sham Comparator

Arm Description

sham anodal stimulation over bitemporal or dorsolateral prefrontal cortex (randomized) and sham cathodal over the orbitofrontal region.

Intervention Type

Device

Intervention Name(s)

Transcranial direct current stimulation (tDCS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT)

Description

List of words

Time Frame

up to 2 weeks

Secondary Outcome Measure Information:

Title

Memory cognitive training

Description

The patients will receive 10 days of episodic memory training.

Time Frame

up to 2 weeks

Title

Attention cognitive training

Description

The patients will receive 10 days of attention training.

Time Frame

up to 2 weeks

Other Pre-specified Outcome Measures:

Title

electroencephalogram - EEG

Description

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

Time Frame

up to 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wellingson S Paiva, MD PhD

Phone

+5511975992245

wellingsonpaiva@yahoo.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Manoel J Teixeira, MD PhD

Phone

+551126610000

manoeljacobsen@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Welligson S Paiva, MD PhD

Organizational Affiliation

professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculdade de Medicina do Hospital das Clinicas HC-FMUSP

City

São Paulo

State/Province

ZIP/Postal Code

05403-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vanessa M Paglioni, BA

Phone

+5511995071977

vanessapaglioni@gmail.com

First Name & Middle Initial & Last Name & Degree

Daniel deCarvalho, BA

Phone

+5511972594210

daniel_carvalho78@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

We need to discuss between the researchers.

Citations:

PubMed Identifier

34446480

Citation

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.

Results Reference

derived

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

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