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DBS for Cognitive Deficits After Traumatic Brain Injury

RecruitingPhase 1Ages 18 Years - 70 YearsAllSunnybrook Health Sciences Centre
NCT06818864 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patients with memory and cognitive deficits following TBI that do not respond to conventional treatments experience a decrease in quality of life. Despite advances in neuroimaging, genetics, pharmacology and psychosocial interventions in the last half century, little progress has been made in altering the natural history of the condition or its outcome. This study would explore whether a surgical therapy is safe and potentially effective in patients who develop refractory memory and cognitive deficits following TBI. Preclinical studies suggest that DBS may improve memory deficits in TBI models. Moreover, DBS delivered to the fornix has shown promising clinical results in patients with Alzheimer's disease. The main mechanism for the improvements induced by DBS in memory tests is the development of multiple forms of plasticity.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Deep Brain Stimulation
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Where

1 site
Sunnybrook Health Sciences Centre
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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