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

NCT ID: NCT04540783

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-12-01

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).

Conditions

Traumatic Brain Injury; Closed Traumatic Brain Injury; Severe Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 - G1

bitemporal anodal stimulation and cathodal stimulation at supraorbital region.

Group Type: ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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.

Group 2 - G2

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

Group Type: ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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.

Group 3 - G3

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

Group Type: SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

WELLINGSON SILVA PAIVA

Supervisor, Division of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Welligson S Paiva, MD PhD

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

Faculdade de Medicina do Hospital das Clinicas HC-FMUSP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Wellingson S Paiva, MD PhD

Role: CONTACT

wellingsonpaiva@yahoo.com.br

+5511975992245

Manoel J Teixeira, MD PhD

Role: CONTACT

manoeljacobsen@gmail.com

+551126610000

Facility Contacts

Vanessa M Paglioni, BA

Role: primary

vanessapaglioni@gmail.com

+5511995071977

Daniel deCarvalho, BA

Role: backup

daniel_carvalho78@yahoo.com.br

+5511972594210

References

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.

Reference Type: DERIVED

PMID: 34446480 (View on PubMed)

Other Identifiers

2241648

Identifier Type: -

Identifier Source: org_study_id