Dr. Jonathan Jagid Conducts FDA Approved Feasibility Clinical Investigation of Deep Brain Stimulation
MARCH 2015 – Deep brain stimulation (DBS) involves a surgical procedure to implant a “brain pacemaker”, which is a device that sends different patterns of electrical stimulation to particular regions of the brain. DBS is already approved by the Food and Drug Administration (FDA) for use in individuals with advanced Parkinson’s disease, essential tremor, dystonia, and obsessive compulsive disorder whose symptoms are inadequately controlled by medication. We wrote an article in our 2013 Research Review magazine about the basic science evaluating the usefulness of DBS after spinal cord injury (SCI) to modulate pain. The region in the midbrain that is target by DBS is called the Periaquaductal Gray, or PAG; electrical stimulation to this region triggers the release of the body’s natural pain relieving molecules.
Led by neurosurgeon Dr. Jonathan Jagid, our multi-disciplinary team is conducting an FDA-approved Feasibility Clinical Investigation of the Medtronic Activa PC DBS device targeting reduction of neuropathic pain and improvement in autonomic dysreflexia in persons living with chronic SCI. The study is collaborative between the University of Miami and the Miami Veterans Administration Hospital and it is funded by the Department of Defense.
Individuals that are eligible for the trial have to meet the following preliminary criteria:
- Spinal cord injury at T12 or above;
- Any severity of spinal cord injury;
- Neuropathic pain at or below level of injury of moderate severity or greater;
- 22-60 years old;
- ≥1 year post-injury.
Individuals that meet the above criteria will undergo more extensive screening as well. Up to 12 participants will be implanted with the device. The implantation involves 2 surgeries, 1st to target the correct area of the brain to implant the leads. The 2nd to implant the remainder of the device including extension cables and pacemaker. So far, two participants have been implanted and more are in various stages of screening.
The primary end goal of the trial is to determine whether DBS can immediately block or reduce ongoing or intermittent SCI pain without acute or long-term adverse reactions. If you or someone you know is interested in learning more about this trial and qualification, please email mpinfo@med.miami.edu