Clinical Research using deep brain stimulation (DBS) for Pain in spinal cord injury

The University of Miami is currently involved in an FDA-approved Clinical Trial investigating DBS for the treatment of neuropathic pain and autonomic dysreflexia in spinal cord injured patients.

Dr. Jonathan Jagid, M.D., is the neurosurgeon and principal investigator of the study. The team is comprised of a multidisciplinary team of basic and clinical researchers, which includes Corneliu Luca, M.D., Ph.D, assistant professor of clinical neurology, and Alberto Martinez-Arizala, M.D., associate professor of neurology, orthopedics, and rehabilitation, who directs the SCI Clinic at the Miami Veterans Administration Hospital.

To be considered for this study, you must be 22-60 years old, and able to read, have a spinal cord injury at segment T12 or above for at least 12 months and have chronic neuropathic pain from this injury that has not responded well to drugs.

Additional inclusion and exclusion criteria exist to be considered for the study. If you are interested in receiving more information, please contact the Study Coordinator:

Letitia Fisher
The Miami Project to Cure Paralysis
University of Miami Miller School of Medicine
305-243-7108
lfisher@med.miami.edu

INTREPID DBS Clinical Trial

• Have you been diagnosed with Parkinson’s disease for 5 years or longer?
• Are you experiencing disabling Parkinson’s disease symptoms or drug side effects despite taking anti-Parkinson’s disease medication(s)?
• Are you 22 to 75 years old?

If you answered “yes” to all these questions, you might be a candidate for a clinical research study, called INTREPID, sponsored by Boston Scientific.

Compensation for time and travel may be available. Participation is voluntary and you may withdraw from the study at any time, for any reason, without penalty.

What’s the purpose of the INTREPID study?
The study team is evaluating the safety and effectiveness of the Vercise™ Deep Brain Stimulation (DBS) system as a therapy for reducing some of the symptoms associated with Parkinson’s disease (PD) that are not adequately controlled with medication.

What is the Vercise™ system?
The Vercise™ system used to administer the DBS therapy sends electrical pulses to an area in your brain called the Subthalamic Nucleus (STN). It consists of an Implantable Pulse Generator (IPG), which is similar in size and shape to a pacemaker. The IPG produces electrical pulses that travel along small wires called leads. Once the leads are placed in the brain, they will be firmly secured and connected to lead extensions which, in turn, will be attached to the IPG. The IPG is typically placed under your skin just below your collar bone.

How long will the study last?
Your participation in this study is expected to last approximately 5.5 years, including screening, device implantation, post-surgical evaluation and follow-up.

What will happen during the study?
The study will include:

Surgery: You will undergo to 3 separate procedures to implant the Vercise™ system, depending on your surgeon’s preference.

Additional details of the study design and follow-up visits will be discussed with you by the study doctor if you are determined eligible for study participation and the DBS procedure.

Will I be responsible for any medical costs?
The pre-authorization from your insurance company, Medicare or Medicaid will be obtained prior to your participation in the study, and they may cover all or certain portions of the surgical costs. Your study coordinator will provide further guidance.

If you are interested please call UM DBS coordinator at 305-243-2781.