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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low frequency | Active Comparator | Programming parameters with the Eon Mini will be set at a low frequency. Subjects will remain in this group for 3 weeks. If subject cannot tolerate this frequency, he/she will meet with the clinical designee for reprogramming. |
|
| High frequency | Active Comparator | Programming parameters with the Eon Mini will be set at a low frequency. Subjects will remain in this group for 3 weeks. If subject cannot tolerate this frequency, he/she will meet with the clinical designee for reprogramming. |
|
| No stimulation | Placebo Comparator | Programming parameters will be set to the lowest possible level and minimal power will be generated. Subjects will remain in this group for 3 weeks. If subject cannot tolerate this frequency, he/she will meet with the clinical designee for reprogramming. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eon-mini IPG (implantable pulse generator) | Device | programming parameters set at low frequency. Patients will receive this therapy dose for 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in persistent cognitive impairments | 24 weeks |
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Inclusion Criteria:
Subjects able to provide informed consent to participate in the study;
Subjects between the ages of 18 and 65;
Subjects with clear evidence and/or documentation of mild traumatic brain injury as defined by the American Congress on Rehabilitation Medicine (1993):
Subjects 12 month post-injury with DSM IV diagnosis of Postconcussive Disorder Research Criteria (see Appendix A for detailed definition):
Subject medication that is TBI-related has remained stable for at least 4 weeks prior to baseline data collection;
Current medical options have been tried and documented without sufficient improvement in symptom control;
Subject agrees not to add or increase any medication throughout the randomization period of the study;
Subject is willing to cooperate with the study requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roni Diaz | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kevin Yoo, MD/Palomar Neurosurgery Ctr | Poway | California | 92064 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Eon-mini IPG (implantable pulse generator) | Device | programming parameters set at high frequency. Patients will receive this therapy dose for 3 weeks. |
|
| Eon-mini IPG (implantable pulse generator) | Device | programming parameters set at lowest settings to deliver minimal power. Patients will receive this therapy dose for 3 weeks. |
|
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |