Actively Recruiting
Deep Brain Stimulation (DBS) for the Treatment of Cognitive Deficits After Traumatic Brain Injury (TBI): Pilot Trial
Led by Sunnybrook Health Sciences Centre · Updated on 2025-02-11
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Traumatic brain injury (TBI) affects millions worldwide and can lead to lasting cognitive problems such as memory and attention difficulties. Despite progress in treatments and research, some patients continue to suffer from severe cognitive deficits that reduce their quality of life. This trial investigates whether deep brain stimulation (DBS), a surgical therapy that has shown promise in improving memory in animal models and Alzheimer's patients, is safe and potentially effective for patients with persistent cognitive issues after TBI. In this study, patients will undergo DBS surgery where electrodes are implanted in specific brain areas using a stereotactic frame to guide precise placement. During the procedure, patients remain awake for part of the surgery while local anesthesia is applied. The trial focuses on targeting brain regions associated with memory and cognitive function. DBS has been used successfully in movement disorders and shows potential for treating neuropsychiatric symptoms after TBI. This trial is a pilot phase assessing the feasibility and safety of this approach. Participants will be closely monitored through regular follow-ups over two years to track any treatment-related side effects and evaluate cognitive changes. Assessments include memory tests and safety evaluations conducted every two weeks initially, then less frequently over time. The study also requires participants to comply with scheduled visits and testing. The main outcome measured is the number of participants experiencing adverse events related to DBS treatment during the follow-up period.
CONDITIONS
Brief 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 traumatic brain injury as defined by DSM-5
- Includes cognitive disorder not otherwise specified, dementia, or amnestic disorder due to TBI
- Performance at least 1.5 standard deviations below estimated premorbid intelligence on memory tests
- History of TBI for at least 1 year with failure to donepezil, cholinesterase inhibitors, and cognitive therapy
- Ability to provide informed consent and comply with all testing, follow-ups, and appointments
You will not qualify if you...
- Active neurologic disease such as epilepsy or Alzheimer's disease
- Contraindication to MRI scanning
- Clinical or neurological conditions increasing surgical risk
- Current suicidal or homicidal ideation
- Pregnancy
- Likely to relocate or move during study duration
- Renal dysfunction with glomerular filtration rate below 60
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgical implantation of deep brain stimulation electrodes targeting specific brain structures to address cognitive deficits following traumatic brain injury.
1 surgical visit (in-person)
Duration - Up to 2 years
Participants are monitored for safety and treatment-related adverse events following surgery, with assessments continuing over two years.
Visits every 2 weeks until 8 weeks, every 4 weeks until 6 months, then every 2 months up to 2 years
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
A
Anusha Baskaran, PhD
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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