"Cognitive Rehabilitation With Direct Current Transcranial Stimulation in Post-Traumatic Brain Injury Patients"

NCT06228872 | Unknown DMC

• 1 other identifier: Resolution number 340
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Cognitive Impairment

Keywords

Transcranial direct current stimulation (tDCS); Computerized cognitive training (CCT); Traumatic brain injury (TBI); Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Executive Cognitive function (Working Memory)

  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

  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 Outcomes (2)

• Mood

  Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).

• Functional Independence

  Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).

Study Arms (2)

Experimental Group

EXPERIMENTAL

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)

Control Group

SHAM COMPARATOR

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)

Interventions

Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS) DEVICE

Computerized Cognitive Training (15 min) + Anodal tDCS over DLPFC (20 min) daily for 1 month

Experimental Group

Cognitive Computerized Training (CCT) plus sham transcranial Direct Current Stimulation (tDCS) DEVICE

Computerized Cognitive Training (15 min) + Sham tDCS over DLPFC (20 min) daily for 1 month

Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mutual de Seguridad Hospital Clinico: lead

Study Sites (1)

Hospital de Mutual de Seguridad

Santiago, Metropolitan Region, Chile

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Brain Injuries, Traumatic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jose M Matamala Capponi, MD

  Associated Professor of the University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia E Del Valle Batalla, MD

CONTACT

+56981486933; luciadelvalle@ug.uchile.cl

Cristian Y Melian, MD

CONTACT

+56994527972; cotomelian@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this trial, masking will ensure blinding of interventions: Participant: They will be unaware of receiving active tDCS therapy or sham intervention. A remote-controlled mobile app will facilitate this. Investigator: They will be masked, not knowing the assigned interventions. This minimizes bias in data collection and analysis. Outcomes Assessor: They will be masked to assigned interventions, ensuring objective and unbiased outcome assessment. Implementing masking ensures that participants, care providers, investigators, and outcomes assessors remain unaware of the intervention received, maintaining trial integrity and validity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a prospective, controlled, double-blind, randomized clinical trial in collaboration with the University of Chile. It includes patients with moderate cognitive impairment due to moderate-to-severe traumatic brain injury lasting over 6 months. Participants will be randomly assigned to the experimental or control group. The intervention involves computerized cognitive training (CCT) through a mobile app and daily self-administered transcranial direct current stimulation (tDCS) therapy to the prefrontal dorsolateral cortex (PFDL) for one month. Prior to the intervention, a training session will instruct patients on device use and adverse effects monitoring. Neuropsychological evaluations will be conducted at baseline (T0), immediately after the last session (T1), and one month later (T2). This trial aims to assess the efficacy of combined CCT and tDCS for cognitive impairment in TBI patients.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: January 29, 2024
• Study Start: January 5, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)