Clinical Trial Details
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NCT02881151 : Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
AgesMin: 22 Years Max: 55 Years
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
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