DBS for Memory Problems After Traumatic Brain Injury
DBS for Cognitive Deficits After Traumatic Brain Injury
Recruiting
Phase 1Interventional Study
TBI Traumatic Brain Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Sunnybrook Health Sciences Centre · Other
Who this trial is looking for
This trial is looking for patients who have memory and thinking problems after a traumatic brain injury that haven’t improved with standard treatments. Participants may undergo a surgical therapy called deep brain stimulation (DBS) to see if it can help improve their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 70 years old.
I have been diagnosed with memory and cognitive deficits after a TBI.
I have cognitive disorder, dementia, or amnestic disorder due to TBI.
I score at least 1.5 standard deviations below my estimated normal intelligence on memory tests.
I have had a traumatic brain injury for at least 1 year and no longer respond to donepezil or other therapies.
I can give my informed consent and keep up with appointments.
You may not be able to join if
I have an active neurologic disease like epilepsy or Alzheimer's.
I can't have an MRI for any reason.
I have conditions that could increase risks during surgery.
I currently have thoughts of suicide or harming others.
I am pregnant.
I am likely to move during the year of the study.
I have kidney problems.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility 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,…
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)
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