Cognitive rehabilitation using brain stimulation for traumatic brain injury patients
Direct Current Transcranial Stimulation as Cognitive Rehabilitation Therapy in Post-Traumatic Brain Injury Patients.
This study is testing if a new brain stimulation method combined with computer exercises can help people with serious thinking problems from a traumatic brain injury improve their mental abilities and mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Mutual de Seguridad Hospital Clinico Academic / other |
| Locations | 1 site (Santiago, Metropolitan Region) |
| Trial ID | NCT06228872 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of daily self-administered transcranial direct current stimulation (tDCS) combined with computerized cognitive training (CCT) on cognitive function in individuals with moderate to severe cognitive impairment due to traumatic brain injury (TBI). Participants will engage in a randomized, controlled, double-blind trial where one group receives anodic tDCS while the control group receives sham stimulation. The study aims to determine if this combined approach improves cognitive function, mood, and overall functionality both immediately and one month after treatment. The intervention will be self-administered by patients or caregivers at home, following a training session on device use.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with moderate to severe TBI and cognitive impairment lasting 6 to 12 months.
Not a fit: Patients with mild cognitive impairment or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance cognitive recovery and quality of life for patients with traumatic brain injury.
How similar studies have performed: Previous studies have shown promising results with tDCS and CCT in cognitive recovery, but this self-administered approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Santiago, Metropolitan Region
- Hospital de Mutual de Seguridad — Santiago, Metropolitan Region, Chile (Recruiting)
Study contacts
- Principal investigator: Jose M Matamala Capponi, MD — Associated Professor of the University of Chile
- Study coordinator: Lucia E Del Valle Batalla, MD
- Email: luciadelvalle@ug.uchile.cl
- Phone: +56981486933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.