Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540783
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
WELLINGSON SILVA PAIVA, University of Sao Paulo General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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) Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Episodic Memory measured by The Rey Auditory-Verbal Learning Test (RAVLT) [ Time Frame: up to 2 weeks ]
    List of words


Secondary Outcome Measures :
  1. Memory cognitive training [ Time Frame: up to 2 weeks ]
    The patients will receive 10 days of episodic memory training.

  2. Attention cognitive training [ Time Frame: up to 2 weeks ]
    The patients will receive 10 days of attention training.


Other Outcome Measures:
  1. electroencephalogram - EEG [ Time Frame: up to 2 weeks ]
    electroencephalogram will be used for safety (Alpha and delta wave)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540783


Contacts
Layout table for location contacts
Contact: Wellingson S Paiva, MD PhD +5511975992245 wellingsonpaiva@yahoo.com.br
Contact: Manoel J Teixeira, MD PhD +551126610000 manoeljacobsen@gmail.com

Locations
Layout table for location information
Brazil
Faculdade de Medicina do Hospital das Clinicas HC-FMUSP Recruiting
São Paulo, SP, Brazil, 05403-000
Contact: Vanessa M Paglioni, BA    +5511995071977    vanessapaglioni@gmail.com   
Contact: Daniel deCarvalho, BA    +5511972594210    daniel_carvalho78@yahoo.com.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Welligson S Paiva, MD PhD professor
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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: September 7, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We need to discuss between the researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System