Peripheral nerve stimulation for the treatment of sequelae due to traumatic brain injury. This study will specifically examine patients with mild traumatic brain injury (TBI) who have persistent cognitive impairments lasting one year or longer. Neuropsychological testing will occur to confirm the diagnosis.
The subject will complete participation in three groups evaluating different programming parameters. After surgery, each subject will be randomized to Group A or Group B. Group C will be completed in the middle followed by the alternate A/B Group. Crossover will occur at 3 week intervals until subjects complete all three groups. During this period, all subjects will receive a subject programmer that will only enable them to activate the "on and off" positions and adjust amplitude within the prescribed range. After subjects have completed the three pre-defined groups they will select the most effective and comfortable setting continuation of the study. The pulse width and frequency parameters will be set to the optimal settings identified by the subject. Amplitude will be set at a level that produces comfortable paresthesia for the subject. Subjects will return to the clinic for programming changes post system internalization at 3 weeks, 6 weeks, and 9 weeks. Subjects will receive a PET scan at the 3 and 9 week visit. Additional follow-up evaluations will occur at 12 weeks, 18 weeks, and 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
3
programming parameters set at low frequency. Patients will receive this therapy dose for 3 weeks.
programming parameters set at high frequency. Patients will receive this therapy dose for 3 weeks.
programming parameters set at lowest settings to deliver minimal power. Patients will receive this therapy dose for 3 weeks.
Kevin Yoo, MD/Palomar Neurosurgery Ctr
Poway, California, United States
Reduction in persistent cognitive impairments
Time frame: 24 weeks
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