DBS for Cognitive Deficits After Traumatic Brain Injury
Deep Brain Stimulation (DBS) for the Treatment of Cognitive Deficits After Traumatic Brain Injury (TBI): Pilot Trial
Sunnybrook Health Sciences Centre
10 participants
Nov 1, 2024
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria6
- Female or male patients between age 18-70.
- 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).
- Patients with cognitive disorder not otherwise specified, dementia, or amnestic disorder due to TBI will be considered.
- 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).
- History of TBI for at least 1 year, preferably with evidence of failure to donepezil, cholinesterase inhibitors and cognitive therapy.
- Ability to provide informed consent and comply with all testing, follow-ups and study appointments.
Exclusion Criteria8
- Active neurologic disease, such as epilepsy or Alzheimer's disease.
- Any contraindication to magnetic resonance imaging (MRI) scanning.
- Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure
- Current suicidal or homicidal ideation.
- Active neurologic disease, such as epilepsy.
- Pregnancy.
- Likely to relocate or move during the study's one year duration
- Patients with renal dysfunction (GFR<60)
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Interventions
Patients will arrive on the morning of surgery to the medical imaging department of the Sunnybrook Hospital. They will have a stereotactic frame attached directly to their skull, after infiltration with local anesthesia. The frame allows precise coordinates to be acquired so that deep brain structures can be targeted with implanted electrodes. The patient will then undergo a CT scan with the frame in place, followed by transport directly to the operating room. The anesthesia team will insert an intravenous line and may use gentle sedation to relax the patient prior to and during the operation, as they will remain awake during the first stage of the operation. In the operating room the patient's head, via the frame, will be attached to the operating room table, and their scalp infiltrated with additional local anesthetic. A skin incision will be made and two burr holeswith approximately 1.4cm in diameter drilled through the skull. A small electrode will identify the optimal spot for ele
Locations(1)
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NCT06818864