Who is eligible for clinical trial NCT06818864?

Participants must meet the protocol's inclusion criteria for TBI Traumatic Brain Injury. The stated age range is 18 Years to 70 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06818864 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-02-07

DBS for Cognitive Deficits After Traumatic Brain Injury (NCT06818864)

Deep Brain Stimulation (DBS) for the Treatment of Cognitive Deficits After Traumatic Brain Injury (TBI): Pilot Trial

🟢 Recruiting Phase1 ⚙️ Medical Device Protocol Sponsor: Sunnybrook Health Sciences Centre

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).

Location: Sunnybrook Health Sciences Centre — Toronto, Ontario

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

Deep Brain Stimulation (DEVICE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Sunnybrook Health Sciences Centre — Toronto, Ontario

📞 Contact the Study Coordinator

Phone: (416) 480-6100

Email: anusha.baskaran@sunnybrook.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in TBI Traumatic Brain Injury

Feasibility of SUPPORT-TBI — St Louis, Missouri
Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy — Boise, Idaho

Explore by condition: All TBI Traumatic Brain Injury clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗