DBS for Cognitive Deficits After Traumatic Brain Injury

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a surgical treatment called Deep Brain Stimulation (DBS) for patients who have memory and thinking difficulties after experiencing a Traumatic Brain Injury (TBI). Many people with TBI struggle with these cognitive issues and do not get better with standard treatments, which can negatively affect their quality of life. The study aims to determine if DBS is safe and could potentially help improve memory and cognitive function in these patients.

To participate in this trial, individuals must be between the ages of 18 and 70 and have been diagnosed with memory and cognitive problems due to TBI that have lasted for at least a year. They should also have tried other medications and therapies without success. The study will involve assessments and follow-ups over a year to monitor the effects of the treatment. It’s important for participants to be able to provide informed consent and commit to the study, as certain health conditions and circumstances might exclude them from participation. Overall, this trial hopes to explore new options for improving the lives of those affected by TBI-related cognitive deficits.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Female or male patients between age 18-70.
• • 2. Diagnosis of memory and cognitive deficits in patients who suffered TBI will be defined according to the Diagnostic and Statistical Manual 5th edition (DSM-5).
• • 3. Patients with cognitive disorder not otherwise specified, dementia, or amnestic disorder due to TBI will be considered.
• • 4. Performance at least 1.5 standard deviations below the estimated premorbid intelligence (assessed by the American National Adult Reading Test) on memory tests (assessed by the California Verbal Learning Test; CVLT).
• • 5. History of TBI for at least 1 year, preferably with evidence of failure to donepezil, cholinesterase inhibitors and cognitive therapy.
• • 6. Ability to provide informed consent and comply with all testing, follow-ups and study appointments.
• Exclusion Criteria:
• • 1. Active neurologic disease, such as epilepsy or Alzheimer's disease.
• • 2. Any contraindication to magnetic resonance imaging (MRI) scanning.
• • 3. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure
• • 4. Current suicidal or homicidal ideation.
• • 5. Active neurologic disease, such as epilepsy.
• • 6. Pregnancy.
• • 7. Likely to relocate or move during the study's one year duration
• • 8. Patients with renal dysfunction (GFR\<60)