Trial Search Results

Deep Brain Stimulation for the Treatment of Traumatic Brain Injury

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Jaimie M. Henderson

Stanford Investigator(s):


  • Device: Deep brain stimulation




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 6-7)

   - 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

Ages Eligible for Study

22 Years - 55 Years

Genders Eligible for Study


Now accepting new patients

Contact Information

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