NCT04540783

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 7, 2020

Status Verified

August 1, 2020

Enrollment Period

9 months

First QC Date

March 9, 2020

Last Update Submit

August 31, 2020

Conditions

Traumatic Brain InjuryClosed Traumatic Brain InjurySevere Brain Injury

Outcome Measures

Primary Outcomes (1)

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

    List of words

    up to 2 weeks

Secondary Outcomes (2)

  • Memory cognitive training

    up to 2 weeks

  • Attention cognitive training

    up to 2 weeks

Other Outcomes (1)

  • electroencephalogram - EEG

    up to 2 weeks

Study Arms (3)

Group 1 - G1

ACTIVE COMPARATOR

bitemporal anodal stimulation and cathodal stimulation at supraorbital region.

Device: Transcranial direct current stimulation (tDCS)

Group 2 - G2

ACTIVE COMPARATOR

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

Device: Transcranial direct current stimulation (tDCS)

Group 3 - G3

SHAM COMPARATOR

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

Device: Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS)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 1 - G1Group 2 - G2Group 3 - G3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • clinical diagnosis closed traumatic brain injury, cognitive complaints reported by the patient or caregiver.

You may not qualify if:

  • metal implants in the head, seizures, abnormal EEG, depressive symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina do Hospital das Clinicas HC-FMUSP

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34446480DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Welligson S Paiva, MD PhD

    professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wellingson S Paiva, MD PhD

CONTACT

+5511975992245wellingsonpaiva@yahoo.com.br

Manoel J Teixeira, MD PhD

CONTACT

+551126610000manoeljacobsen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
sham device (by code)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor, Division of Neurosurgery

Study Record Dates

First Submitted

March 9, 2020

First Posted

September 7, 2020

Study Start

September 1, 2020

Primary Completion

June 1, 2021

Study Completion

December 1, 2022

Last Updated

September 7, 2020

Record last verified: 2020-08

Locations

BR(1)