PATIENT SELECTION: PARKINSON’S DISEASE DEEP BRAIN STIMULATION
Best results are achieved when the patient and caregiver are fully informed about the therapy risks and benefits, surgical procedures, follow-up requirements, and self-care responsibilities.
Consider deep brain stimulation when a patient has:
A patient must also be a suitable candidate for stereotactic neurosurgery.
In 2002, the FDA initially approved Medtronic DBS Therapy for use in patients with advanced Parkinson’s disease. Medtronic DBS of the STN improved quality of life and motor function as shown in a Level I evidence clinical study of patients of at least 4 years disease duration and recent onset of motor complications.1 Based on the clinical evidence, in 2015 the FDA approved Medtronic DBS Therapy for use in people with Parkinson’s disease starting with those who have recent onset of motor complications. This means clinicians no longer have to delay consideration of Medtronic DBS Therapy until the disease has become debilitating.
Medtronic DBS Therapy is also appropriate for patients with longer-standing motor complications, and there is no upper age limit restriction, as shown in a post-approval Level 1 evidence clinical trial.2
The safety and effectiveness of deep brain stimulation therapy for Parkinson's disease have not been established for patients who:
Use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.
Physicians should be aware that the risks associated with initial surgery may increase with clinical conditions such as:
To help ensure maximum benefits from the neurostimulation system, long-term, post-surgical management of patients is recommended.
Stimulation parameters should be adjusted such that maximal symptom suppression is achieved with minimal side effects. High parameter values may indicate a system problem or less than optimal lead placement. Patients should be informed of the risks of higher parameters as noted in the appropriate information for prescribers booklet.
Clinicians may refer candidates to a DBS multidisciplinary center for a comprehensive evaluation for possible Medtronic DBS Therapy.
The evaluation usually includes:
Deep brain stimulation for Parkinson's disease has a window of opportunity when it may be most effective.
The window opens when a patient has Parkinson's disease of at least 4 years' duration that is not adequately controlled by medication, including motor complications for at least 4 months or motor complications of longer-standing duration. You may observe one or more of the following:
The window closes when:
Introducing patients to DBS as a future option can help prepare them to start therapy in time to take advantage of their window of opportunity.
Schuepbach WMM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson’s disease with early motor complications. N Engl J Med. February 14, 2013; 368:610-622.
Medtronic DBS Therapy for Parkinsons’ Disease and Essential Tremor Clinical Summary, 2015.