"Cognitive Rehabilitation With Direct Current Transcranial Stimulation in Post-Traumatic Brain Injury Patients" (tDCS-TEC)

January 24, 2024 updated by: Mutual de Seguridad Hospital Clinico

Direct Current Transcranial Stimulation as Cognitive Rehabilitation Therapy in Post-Traumatic Brain Injury Patients.

The goal of this clinical trial is to investigate the impact of daily self-administered transcranial direct current stimulation (tDCS) therapy on the cognitive function of individuals with moderate to severe cognitive impairment resulting from a traumatic brain injury (TBI). The study aims to answer the following questions:

Does daily self-administered tDCS therapy, when combined with computerized cognitive training (CCT), improve cognitive function in TBI patients? Is CCT+tDCS with anodic stimulation more effective than CCT+tDCS with simulated stimulation in enhancing immediate and one-month post-treatment cognitive function? Does CCT+tDCS with anodic stimulation lead to better functionality immediately and one month after treatment compared to CCT+tDCS with simulated stimulation? Does CCT+tDCS with anodic stimulation have a positive impact on mood improvement immediately and one month after treatment compared to CCT+tDCS with simulated stimulation? Participants in the study will engage in CCT through a smartphone or tablet application and self-administer tDCS therapy for 20 minutes each day for a duration of one month. The tDCS therapy will involve applying a 2 mA anodic current to the prefrontal dorsolateral cortex (PFDL). Prior to the intervention, patients or their caregivers will receive training on the proper and safe usage of the tDCS device. Cognitive function, mood, and functionality will be evaluated before and after the intervention using appropriate measurement scales.

The outcomes of this clinical trial have the potential to identify an effective and accessible therapeutic approach to enhance cognitive function in individuals with moderate to severe TBI. The combination of tDCS therapy with CCT offers an appealing and feasible treatment strategy for these patients, particularly when conducted in a home setting. The findings from this study will guide future clinical trials in the field of cognitive rehabilitation for TBI patients. Researchers will compare active tDCS with sham tDCS to determine if there are differences in the primary outcomes mentioned.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that can modulate neuronal excitability and enhance neuroplasticity. On the other hand, computerized cognitive training (CCT) therapy uses computers to improve cognitive domains through repeated practice of theoretically-driven skills and strategies. So far, the isolated use of tDCS and its combination with CCT have been explored in the cognitive recovery of patients with traumatic brain injury (TBI), yielding promising results. However, none of the studies to date have investigated the use of a self-administered therapy (by the patient and/or caregiver) that combines both interventions at home. The objective of this clinical trial is to evaluate the effect of daily self-administered tDCS therapy on cognitive function in patients with moderate-to-severe TBI-associated cognitive impairment.

Methodology: A prospective, controlled, double-blind, randomized clinical trial is proposed. The intervention will consist of (i) CCT delivered through a smartphone or tablet application and (ii) the application of 2 mA tDCS therapy (20 minutes of anodic current for the experimental group and 60 seconds for the control group) to the prefrontal dorsolateral cortex (PFDL) daily for one month, self-administered by the patient. Prior to the intervention, a training session will be conducted to instruct the patient (or caregiver) on the correct and safe use of the device. The primary outcomes will be cognitive function, mood, and functionality, measured before and after the intervention using appropriate scales.

Discussion: The results of this clinical trial could contribute to the identification of an effective and accessible therapeutic method to improve cognitive function in patients with moderate-to-severe TBI. The combination of tDCS therapy with CCT may offer an attractive and feasible therapeutic strategy for these patients, particularly when performed at home. The findings of this study may be useful in guiding future clinical trials in the field of cognitive rehabilitation in TBI patients.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Chile
    • Metropolitan Region
      • Santiago, Metropolitan Region, Chile
        • Recruiting
        • Hospital de Mutual de Seguridad
        • Contact:
        • Principal Investigator:
          • Lucia E Del Valle Batalla, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18-65 years.
  • Moderate to severe traumatic brain injury (TBI) according to classification 58 (see Table 3) with a duration of 6 to 12 months.
  • Minimum of 8 years of education (completed basic education with literacy skills).
  • Meeting diagnostic criteria (see Table 3) for mild or major cognitive impairment according to the Diagnostic and Statistical Manual of Mental Disorders (DSM).
  • Capacity to make decisions and understand relevant information regarding participation in a clinical trial, assessed using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) 60.
  • Inclusion of patients with chronic TBI (defined for this study as more than 6 months of duration) based on the proposed mechanism of chronic TBI involving decreased cerebral neuroplasticity, leading to long-term cognitive dysfunction and functional limitations 62. Transcranial Direct Current Stimulation (tDCS) has shown effectiveness in enhancing neuroplasticity in various neurological and psychiatric conditions 63.

Exclusion Criteria:

  • History of cognitive impairment unrelated to post-traumatic causes (for which the patient is being treated at Mutual de Seguridad).
  • History of epileptic seizures.
  • Pre-existing neuropsychiatric disorders.
  • Presence of metallic objects in the body such as aneurysm implants, hemostatic clips, implanted electrodes, and electrical devices like pacemakers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Participants will receive Computerized Cognitive Training and anodal tDCS daily for one month. Stimulation will consist of 20 min of anodal 2mA tDCS stimulation over the DLPFC, followed by 15 min of computerized cognitive training.
Device: Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS)
Computerized Cognitive Training (15 min) + Anodal tDCS over DLPFC (20 min) daily for 1 month
Sham Comparator: Control Group
Participants will receive Computerized Cognitive Training and sham tDCS daily for one month. Sham stimulation will consist of 60 seconds of anodal 2mA tDCS stimulation over the DLPFC, followed by 19 mins of no current delivery. The same 15 min of computerized cognitive training will be provided after the end of the Sham Stimulation.
Device: Cognitive Computerized Training (CCT) plus sham transcranial Direct Current Stimulation (tDCS)
Computerized Cognitive Training (15 min) + Sham tDCS over DLPFC (20 min) daily for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive Cognitive function (Working Memory)
Time Frame: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Measurement of working memory using Digit Span forward and backward.
Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Executive Cognitive Function
Time Frame: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Assessment of general executive cognitive function using Ineco Frontal Screening (IFS) evaluation.
Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Assessment of mood using the Structured Clinical Interview for Depression (SCID) to detect depressive symptoms.
Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Functional Independence
Time Frame: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Evaluation of functional independence using the Functional Independence Measure (FIM) associated with the Functional Assessment Measure (FAM). FIM assesses independence in various domains of activities of daily living, while FAM is used to measure functionality and performance in daily activities.
Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mutual de Seguridad Hospital Clinico

Investigators

  • Principal Investigator: Jose M Matamala Capponi, MD, Associated Professor of the University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Resolution number 340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Impairment

Clinical Trials on Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe