Traumatic Brain Injury Peripheral Nerve Study (TBI)

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury Read More

Inclusion Criteria:

1. Subjects able to provide informed consent to participate in the study;
2. Subjects between the ages of 18 and 65;

3. Subjects with clear evidence and/or documentation of mild traumatic brain injury as defined by the American Congress on Rehabilitation Medicine (1993):

   • Closed head injury/trauma
   • Score of 13-15 on the Glasgow Coma Scale
   • Documented/witnessed loss of consciousness < 30 minutes post injury
   • Post traumatic amnesia less than 24 hours post injury.

4. Subjects 12 month post-injury with DSM IV diagnosis of Postconcussive Disorder Research Criteria (see Appendix A for detailed definition):

   • Evidence from neuropsychological testing of difficulty in attention or memory
   • Complaints, at baseline, of three or more postconcussive symptoms that have been present at least 3 months.
5. Subject medication that is TBI-related has remained stable for at least 4 weeks prior to baseline data collection;
6. Current medical options have been tried and documented without sufficient improvement in symptom control;
7. Subject agrees not to add or increase any medication throughout the randomization period of the study;
8. Subject is willing to cooperate with the study requirements.

Exclusion Criteria:

1. Subject diagnosed with a terminal disease (ie. cancer, leukemia, or advanced stages of disease resulting in less than 12 months life expectancy);
2. Subject currently participating in another clinical study;
3. Subject with demand-type cardiac pacemakers, an infusion pump or any implantable device (ie. deep brain stimulators, spinal cord stimulators, CSF shunts, aneurism clip and cochlear implants) which may interfere with therapy;
4. Subject with significant depression and/or other significant psychiatric/behavioral problems likely to interfere with study completion or result in addition distress to the subject as determined by a qualified Psychiatrist or psychologist;
5. Subject with an existing medical condition that is likely to require repetitive MRI evaluation in the future (ie. epilepsy, stroke, acoustic neuroma, tumor);
6. Subject with a history of open head trauma;
7. Subject with visual, hearing or motor deficits that impair ability to complete neurocognitive testing;
8. Subject with a history of moderate to severe TBI;
9. Subject with post traumatic seizure disorder;
10. Subject with history of learning disability and/or ADHD
11. Subject with history of chronic headache syndrome prior to post-concussive disorder;
12. Subject is not willing to maintain current TBI-related medication regimen;
13. Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception (ie. oral contraceptives, injectibles, implants, patches, condoms, barrier methods, spermicides, intrauterine devices, and sterilization), or nursing (lactating) a child.