Actively Recruiting
DBS for Cognitive Deficits After Traumatic Brain Injury
Led by Sunnybrook Health Sciences Centre · Updated on 2025-02-11
10
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DBS for Cognitive Deficits After Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male patients between age 18-70
- Diagnosis of memory and cognitive deficits after TBI according to DSM-5
- Includes cognitive disorder not otherwise specified, dementia, or amnestic disorder due to TBI
- Memory test performance at least 1.5 standard deviations below estimated premorbid intelligence
- History of TBI for at least 1 year with failed donepezil, cholinesterase inhibitors, and cognitive therapy
- Ability to provide informed consent and comply with all study visits and testing
You will not qualify if you...
- Active neurologic disease such as epilepsy or Alzheimer's disease
- Contraindication to MRI scanning
- Clinical or neurological conditions that significantly increase surgical risk
- Current suicidal or homicidal ideation
- Pregnancy
- Likely to relocate during the one-year study
- Renal dysfunction with GFR less than 60
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
A
Anusha Baskaran, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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