CENTURY-S | Traumatic brain injury trial
Has your work performance been affected by a traumatic brain injury?
If so, you may be qualified to participate in this clinical study.
Has your work performance been affected by a traumatic brain injury? If so, you may be qualified to participate in this clinical study.
Frequently Asked Questions
What is the goal of the research?
Our goal is to validate the use of the deep brain stimulator for the treatment of traumatic brain injuries. Particularly, we hope this system will help patients with memory functioning, attention and focus, and fatigue.
How long is the study?
The study is about a year for those who complete the entire study. You are free to withdraw from the research at any time during your participation.
Has this surgery been performed before?
Yes, this device is currently FDA-approved for the treatment of tremor associated with Parkinson’s disease as well as other indications. This is the first time we are using this system for patients with traumatic brain injuries.
Is the surgery risky?
Like all medical procedures, there is some risk associated with the implant surgery. The most common is the risk of infection, although the incidence of infection is still quite low. For a full description of risks, please contact the study coordinator.
What happens if there are complications?
Depending on the type of complication, we can decide whether or not to keep the system implanted. If we feel you are at a higher risk for injury if the system remains implanted, we will remove the system through an explant surgery.
What happens after the study is completed?
If the system works for you, you will be able to keep the system implanted after the study is completed at no cost to you. You will need to transfer your care to your local neurology department to maintain the system.
What is the long-term care of the deep brain stimulator?
The system is generally maintenance-free once the system is calibrated for your use. If you are exposed to high magnetic fields, your device may be turned off and will need to be recalibrated. The battery pack implanted under the skin of the chest will need to be replaced every 3-5 years, which will require a minor surgery.
Details for the study
Treatments and/or Procedures
Inclusion Criteria: - History of moderate to severe TBI based on worst GCS score within first 48 hours of injury (acceptable GCS range = 3-9) - Age 22-55 - At least 24 months from date of onset - Fluent in English and able to independently provide consent - Rating of upper moderate disability to lower good recovery on the Glasgow Outcome Scale-Extended (GOSE) at time of enrollment (acceptable GOSE range 5-7) - Performance ≥ 2 SD's below the demographically-corrected mean on at least one attention, memory or executive function measure at baseline - Failure to return to pre-injury level of vocational or educational function - Either receiving no CNS stimulants or other medications known to affect cognitive function, or on stable doses of these medications for the last three months Exclusion Criteria: - History of major developmental, neurologic, psychiatric or substance use disorder with evidence of disability prior to onset of TBI - Major medical co-morbidities including: end stage renal failure, severe heart failure, coagulopathy, severe respiratory problems, severe liver failure, uncontrolled hypertension or other significant medical co morbidities - Have had a documented seizure within 3 months of study screening (subjects may re-screen if seizure free after initial screen failure) - Malignancy with < 5 years life expectancy - Untreated / uncontrolled (severe at the time of enrollment) depression or other psychiatric disorder - Women of childbearing age who do not regularly use an accepted contraceptive method - Inability to stop anticoagulation therapy or platelet anti-aggregation therapy before, during and after surgery - Previous DBS or other brain implants - Previous ablative intracranial surgery - Implantable hardware not compatible with MRI - Condition requiring diathermy after DBS implantation - Hardware, lesions or other factors limiting placement of electrodes in optimal target location in the judgment of the operating surgeon - Concurrent enrollment in any other clinical trial - Any condition or finding that, in the judgment of the PI, significantly increases risk or significantly reduces the likelihood of benefit from DBS