Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT02881151
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
60 Years
Study:
NCT02881151
Study Brief:
Protocol Section:
NCT02881151