Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation. Although all patients will receive stimulation continuously through a surgically implanted pacemaker-like device, half of the patients will have the device deactivated during a blinded assessment phase. The device will be reactivated following this assessment and patients will have the option to continue stimulation in an open-label continuation.
Official Title
CT-DBS for Traumatic Brain Injury Using the Medtronic Activa PC+S System
Eligibility Criteria
- - History of moderate to severe TBI based on worst GCS score within first 48 hours of injury (acceptable GCS range = 3-12) - Age 22-60 - 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) - 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
- - 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Jaimie M Henderson, MD
650-723-5574
View on ClinicalTrials.gov
