Vagus Nerve Stimulation Clinical Trials
Investigators in NYU Langone’s Department of Neurosurgery conduct clinical research on vagus nerve stimulation. Under the direction of Werner K. Doyle, MD, 12 subjects participate in a prospective, randomized, crossover pilot study for 18 months after vagus nerve stimulator implantation. Subjects cross over between no stimulation (device off) and stimulation (device on) every 3 months for 6 periods, yielding a total trial time of 18 months. The trial is blinded in that neither subjects nor researchers assessing outcomes know whether the devices are on or off. Outcomes will be assessed using clinical scales, eye movement tracking, and functional MRI.
Patient Enrollment Criteria
Subjects must be able to receive care in the VA NY Harbor Healthcare System in order to be eligible for this study. Inclusion criteria include being between 18 and 60 years old and having sustained a moderate to severe traumatic brain injury (defined as ranking on the Disability Rating Scale between 18 and 29 and occurring between 4 and 10 months before starting the study, with or without concurrent seizure activity). Although patients who have had craniotomies may be enrolled in the study, those with hydrocephalus or active intracranial pressure elevation will be excluded because treatment of their ongoing neurosurgical disease will confound evaluation of outcomes.
Exclusion criteria include prior vagotomy, retained metal contraindicating an MRI, concurrent active severe medical problems that render surgery to place the device unsafe, a history of sleep apnea, myocardial infarction or arrest, cardiac conduction abnormalities, and conditions that could prevent the patient from surviving the duration of the study. Pregnancy or intent to become pregnant during the course of the study will also result in exclusion. Patients with pre-existing central nervous system disease or associated comorbidities that might prevent 18 months of follow-up will also be excluded. Stable orthopedic or other traumatic body injuries are not a contraindication.
Disability Rating Scale (Abridged)
| Modality Tested | Score |
|---|---|
| Eye Opening | |
| Spontaneous | 0 |
| To speech | 1 |
| To pain | 2 |
| None | 3 |
| Communication Ability | |
| Oriented | 0 |
| Confused | 1 |
| Inappropriate | 2 |
| Incomprehensible | 3 |
| None | 4 |
| Motor Response | |
| Obeying | 0 |
| Localizing | 1 |
| Withdrawing | 2 |
| Flexing | 3 |
| Extending | 4 |
| None | 5 |
| Feeding (Cognitive Ability Only) | |
| Complete | 0 |
| Partial | 1 |
| Minimal | 2 |
| None | 3 |
| Toileting (Cognitive Ability Only) | |
| Complete | 0 |
| Partial | 1 |
| Minimal | 2 |
| None | 3 |
| Grooming (Cognitive Ability Only) | |
| Complete | 0 |
| Partial | 1 |
| Minimal | 2 |
| None | 3 |
| Level of Functioning | |
| Completely Independent | 0 |
| Independent in special environment | 1 |
| Mildly dependent | 2 |
| Markedly dependent | 3 |
| Moderately dependent | 4 |
| Totally dependent | 5 |
| Employability | |
| Not Restricted | 0 |
| Selected Jobs | 1 |
| Sheltered Workshop | 2 |
| Not Employable | 3 |
Contact Us
To learn more about clinical trials of vagus nerve stimulation, please contact Dr. Doyle at 646-558-0804 or werner.doyle@nyulangone.org.
