Deep Brain Stimulation for the Treatment of Traumatic Brain Injury

Not Recruiting

Trial ID: NCT02881151


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

Stanford Investigator(s)


Inclusion 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

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


device: Deep brain stimulation

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jaimie M Henderson, MD