Parkinson’s disease affects nearly 10 million people worldwide and its prevalence has doubled in the past 25 years. The disease, neurodegenerative, precisely affects brain cells in a specific area of the brain that produce dopamine. Symptoms include tremors, stiffness, difficulty with balance and coordination, loss of mobility and independence. Its current treatments include drugs and deep brain stimulation which requires the surgical implantation of electrodes in the brain. The drugs can cause severe side effects, including involuntary movements (dyskinesia) and not all patients respond to the drugs.
There is therefore a considerable – and growing – need for new treatments.
This trial shows, in summary, that treated by this type of focused ultrasound, participants with Parkinson’s disease benefited from a significant reduction in their tremors, an improvement in their mobility and an overall reduction their other physical symptoms.
“The focused ultrasound was really beneficial. Much of my fine motor skills have returned. I’m putting eyeliner back on and I’m taking showers again without falling,”
says one of the treated participants.
“These results are very promising and offer Parkinson’s patients a new option to manage their symptoms”says one of the lead authors, Dr. Howard Eisenberg, professor of neurosurgery and neurosurgeon at UMMC.
No incision, no complications
The clinical trial, multi-site, involved 94 patients with Parkinson’s disease assigned to undergo focused ultrasound treatment to remove a targeted region on one side of the brain (intervention group) or to undergo a sham procedure (control group). Experience shows that:
- nearly 70% of patients in the intervention group responded well to treatment after 3 months of follow-up;
- two-thirds of these patients who responded successfully to treatment maintain these improvements one year later;
- adverse events from the procedure included headache, dizziness, and nausea that resolved within 1 or 2 days; some patients have also experienced mild and transient side effects, including slurred speech, walking and loss of taste (dysgeusia).
The authors hope this data will help doctors and patients make an informed decision when considering treatment to manage the symptoms of the disease. “It is important for patients to realize that none of the treatments currently available cure Parkinson’s disease”adds one of the co-authors of the study, Dr. Paul Fishman, professor of neurology.
Focused ultrasound is an incisionless procedure, performed without anesthesia or hospitalization. Patients, who remain perfectly alert, lie in a magnetic resonance imaging (MRI) scanner and wear headphones. Ultrasonic energy is targeted through the skull to the globus pallidus, a structure deep in the brain involved in controlling regular voluntary movement. MRI images provide physicians with a real-time temperature map of the treated area, to precisely locate the target and apply high enough temperature for ablation. During the procedure, the patient is awake and provides feedback, allowing doctors to monitor the immediate effects of tissue removal and make any necessary adjustments.
Here, the “Exablate Neuro” device, approved more than a year ago by the Food and Drug Administration (FDA) to treat advanced asymmetric Parkinson’s disease, was used.
“We are at the forefront of focused ultrasound technology and continue to evaluate the procedure in different areas of the brain affected by Parkinson’s disease, such as the subthalamic nucleus, which controls movement regulation. We are also looking at how the technique could help temporarily open the blood-brain barrier to help deliver experimental treatments for Parkinson’s disease to the brain.”
The study was funded by Insightec, maker of Exablate Neuro.