Search / Trial NCT06228872

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

Launched by MUTUAL DE SEGURIDAD HOSPITAL CLINICO · Jan 24, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Transcranial Direct Current Stimulation (T Dcs) Computerized Cognitive Training (Cct) Traumatic Brain Injury (Tbi) Cognitive Impairment

ClinConnect Summary

This clinical trial is studying a new way to help people with moderate to severe cognitive problems caused by traumatic brain injuries (TBI). The researchers want to find out if a combination of a special brain stimulation technique called transcranial direct current stimulation (tDCS) and computerized cognitive training (CCT) can improve thinking abilities, mood, and daily functioning in these patients. Participants will use a smartphone or tablet app for cognitive training and apply the tDCS device themselves for 20 minutes each day, for a month. They will receive training on how to use the device safely before starting.

To be eligible for this study, participants need to be between 18 and 65 years old, have had a TBI for at least 6 months, and have some level of cognitive impairment. They should also have completed basic education and be able to understand the study information. Throughout the trial, the researchers will evaluate how well the combination of tDCS and CCT works by measuring changes in cognitive function and mood before and after the treatment. This trial could lead to an effective and easy way for people with TBI to improve their thinking skills from the comfort of their homes.

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Jose M Matamala Capponi, MD

Principal Investigator

Associated Professor of the University of Chile

About Mutual De Seguridad Hospital Clinico

Mutual de Seguridad Hospital Clínico is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a strong emphasis on patient safety and ethical standards, the hospital integrates cutting-edge technology and a multidisciplinary approach to provide comprehensive care. Its commitment to scientific excellence and collaboration with healthcare professionals positions it as a pivotal player in the field of clinical research, fostering advancements in treatment modalities and enhancing the overall quality of healthcare delivery.

Locations

Santiago, Metropolitan Region, Chile

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0