Deep Brain Stimulation for cognitive issues after brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ReVIVE for mTBI: Using VR and therapy to help adults with mild traumatic brain injury

  This study tests a virtual reality therapy combined with standard psychotherapy to see if it can reduce PTSD symptoms and improve executive function in adults with mild traumatic brain injury.

  Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT07890337

• Fibrinogen-to-Albumin Ratio as a Predictor of ARDS in Traumatic Brain Injury

  This study tests whether the fibrinogen-to-albumin ratio can predict who among adults with traumatic brain injury will develop acute respiratory distress syndrome (ARDS).

  Recruiting Tanta University · Tanta, Gharbia Governorate · NCT07664358

• Support-TBI: Testing a partner-based program to help people with traumatic brain injury stay connected

  A small pilot test will see if a partnered person with TBI and a close supporter can successfully participate in a 12-week program to improve social support and daily life participation.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT07625098

• ENGAGE-TBI: A Feasibility Program to Reduce Social Isolation for Adults with Traumatic Brain Injury

  We’re testing a 12-session group program to help adults with traumatic brain injury in the community build social participation and reduce isolation.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT07549997

• Can a bedside brain scan (fNIRS) detect activity in healthy people and in people with disorders of consciousness

  This observational study tests whether functional near-infrared spectroscopy (fNIRS) can measure brain activity at the bedside in healthy adults and in patients with disorders of consciousness in the Neuro-ICU.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07485361

• Long-lasting effects of hyperbaric oxygen therapy on thinking after traumatic brain injury

  This project will see if people with traumatic brain injury who completed a course of hyperbaric oxygen therapy 1–4 years ago still have improved thinking and memory.

  Recruiting Assaf-Harofeh Medical Center · Zrifin · NCT07430150

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.