NCT01588691

Traumatic Brain Injury Peripheral Nerve Study

A Feasibility Study to Examine the Efficacy of C2-C3 Dermatomal Peripheral Nerve Stimulation in Cognitive Improvements Following Persistent Impairment After Traumatic Brain Injury

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Eon-mini IPG (implantable pulse generator)	programming parameters set at low frequency. Patients will receive this therapy dose for 3 weeks.
DEVICE	Eon-mini IPG (implantable pulse generator)	programming parameters set at high frequency. Patients will receive this therapy dose for 3 weeks.
DEVICE	Eon-mini IPG (implantable pulse generator)	programming parameters set at lowest settings to deliver minimal power. Patients will receive this therapy dose for 3 weeks.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-04-01
• Completion: 2014-11-01
• First posted: 2012-05-01
• Last updated: 2019-02-04

Locations

1 site across 1 country: United States