Deep Brain Stimulation for cognitive issues after brain injury
Deep Brain Stimulation (DBS) for the Treatment of Cognitive Deficits After Traumatic Brain Injury (TBI): Pilot Trial
This study is testing whether Deep Brain Stimulation can help improve memory and thinking skills in people who have cognitive issues after a traumatic brain injury that haven't gotten better with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06818864 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and potential effectiveness of Deep Brain Stimulation (DBS) in patients suffering from memory and cognitive deficits following a traumatic brain injury (TBI) that have not responded to conventional treatments. The research aims to explore how DBS, which has shown promise in improving memory deficits in preclinical studies and in Alzheimer's patients, can alter the natural history of cognitive impairments associated with TBI. Participants will undergo a thorough evaluation to determine their eligibility based on specific cognitive criteria and treatment history. The study seeks to provide insights into the neuroplasticity mechanisms that may be activated by DBS to enhance cognitive function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with diagnosed cognitive deficits due to TBI who have not responded to standard treatments.
Not a fit: Patients with active neurological diseases or contraindications to MRI scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive function and quality of life for patients with refractory memory deficits after TBI.
How similar studies have performed: While DBS has been widely used in other neurological conditions, this specific application for TBI-related cognitive deficits is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Nir Lipsman, MD PhD — Sunnybrook Health Sciences Centre
- Study coordinator: Anusha Baskaran, PhD
- Email: anusha.baskaran@sunnybrook.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.