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New treatment option for TBI Traumatic Brain Injury
Official title DBS for Cognitive Deficits After Traumatic Brain Injury
ClinicalTrials.gov ID: NCT06818864
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
- History of TBI for at least 1 year, preferably with evidence of failure to donepezil, cholinesterase inhibitors and cognitive therapy.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.