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Focused-ultrasound Lesion Surgery Can Treat Tremors and Improve Life Quality, Study Says

tremors and surgery

Treating tremor in Parkinson’s patients using non-invasive and focused-ultrasound lesion surgery is associated with better quality of life when compared to deep brain stimulation, although both approaches are equally effective in easing this disease symptom, a review study reports.

The study, “Outcomes in Lesion Surgery versus Deep Brain Stimulation in Patients with Tremor: A Systematic Review and Meta-analysis,” was published in the journal World Neurosurgery.

At least 50 percent of people with Parkinson’s, essential tremor (ET) or multiple sclerosis (MS) given oral medications as a first-line treatment for tremor — defined as an involuntary, uncontrollable muscle contraction; most commonly in the hands — do not tolerate these medications over the long term.

Current alternatives include deep brain stimulation (DBS) and lesion surgery (LS), which induces lesions on targeted areas using a heated electrode or focused ultrasound. Prior comparisons have shown that while the two techniques are equally effective in suppressing tremor, DBS led to a greater improvement in function.

But LS with focused ultrasound is gaining in popularity, and one study suggested that it may significantly improve tremor and quality of life.

Researchers at Harvard Medical School conduced a systematic review and a meta-analysis — a type of statistical study that combines the results of various studies — to determine which strategy is most effective in diminishing tremor severity and improving life quality and function in people with Parkinson’s, ET, or MS.

Three online databases were searched for results of randomized clinical trials published up to Jan. 1, 2018, and that included adults treated with either LS or DBS, or serving as controls. Both DBS and LS studies targeted unilateral or bilateral thalamus, pallidum or subthalamic nucleus, all of which are implicated in motor function.

Thirteen Parkinson’s trials were among the 15 included in this study, and the primary outcome for all but one was change in upper limb tremor severity, as assessed with the unified Parkinson’s disease rating scale (UPDRS) part III. Changes in quality of life, cognitive function and neuropsychiatric function were also assessed with variable measures.

A total of 1, 508 patients (mean age range, 48.4 to 70.8) were included, and in addition to the 13 studies involving only Parkinson’s patients, one study looked at people with Parkinson’s, ET and MS, while the remaining study was in people with severe ET.

Four of the 15 trials — involving 125 patients — directly compared DBS to LS. The others compared either LS or DBS with controls.

Results showed that DBS and LS were not significantly different across all analyzed outcomes, which is in line with current guidelines, the researchers noted. All but one trial showed both these types of surgery eased tremor severity. Quality of life findings showed variability in outcomes, which was driven by disease duration. Specifically, longer disease duration correlated with a greater likelihood of surgery and better quality of life.

A subgroup analysis that looked specifically at LS using focused ultrasound revealed that this approach was associated with a significant improvement in quality of life compared to DNS, although changes in tremor severity were similar.

“Policy makers, healthcare providers, and patients could therefore consider focused-ultrasound [LS] as a potential choice for tremor control, based on currently available evidence,” the researchers wrote.

However, results from more studies directly comparing DBS with focused-ultrasound LS are needed, they advised.

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First Parkinson’s Patient Treated with Insightec’s Incisionless Brain Therapy

Insightec

Insightec has treated the first patient in a pivotal study of its non-invasive ultrasound therapy, ExAblate Neuro, for patients with advanced Parkinson’s who have not responded to medication.

The device uses focused ultrasound and magnetic resonance imaging (MRI) to destroy a target deep in the brain — the Vim nucleus of the thalamus — through an intact skull. This area has been identified as responsible for causing Parkinson’s tremors. The MRI technology enables physicians to guide treatment planning and deliver thermal feedback in real-time monitoring.

The therapy aims to improve motor function and treat the characteristic involuntary movements of arms and legs, which may occur as a side effect of medication, and impair patients’ quality of life and ability to perform daily activities.

In July 2016, Insightec’s therapy become the first focused ultrasound device approved by the U.S. Food and Drug Administration (FDA) for the treatment of medication-resistant essential tremors with non-invasive thalamus destruction. In October 2017 the FDA granted approval to initiate the trial for these patients.

The trial (NCT03454425) evaluates the safety and effectiveness of the ExAblate System for the treatment of Parkinson’s motor features. It is currently enrolling patients who are 30 or older and have predominant motor disability from one side of the body. Insightec plans to recruit a total of 40 participants and expects to complete the research by December 2020.

“Building on the success of the incisionless focused ultrasound treatment for essential tremor, we are excited to extend its application to the debilitating effects of Parkinson’s,” Howard Eisenberg, MD, the study’s principal investigator and a neurosurgery professor at the University of Maryland School of Medicine, said in a press release.

Eisenberg is recognized as one of the nation’s top neurosurgeons and an expert on traumatic brain injury and the blood brain barrier.

“INSIGHTEC is committed to supporting focused ultrasound research, which is much less invasive than conventional surgery, and has the potential of improving the lives of people living with Parkinson’s,” said  Maurice R. Ferré, MD, CEO at Inisightec.

The company recently began a parallel Phase 3 trial (NCT03319485) of its MRI-guided focused ultrasound system for treating motor symptoms in Parkinson’s. It plans to recruit more than 100 patients with advanced idiopathic Parkinson’s not responding to available therapies. Patient enrollment is ongoing at sites in Maryland, New York, Ohio, Pennsylvania, and Virginia. More information is available here.

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Source: Parkinson's News Today

MRI-Focused Ultrasound Undergoing Phase 3 Clinical Trial for Parkinson’s Treatment

focused ultrasound

New technology that uses MRI-guided focused ultrasound to target areas of the brain affected by Parkinson’s disease and improve motor symptoms will be further tested in a pivotal Phase 3 clinical trial.

Led by the University of Maryland Medical Center (UMMC) and the University of Maryland School of Medicine (UMSOM), the randomized trial will assess the safety and effectiveness of the novel procedure. It is the final step before the U.S. Food and Drug Administration (FDA) will consider approving it as a nonsurgical treatment for  Parkinson’s.

“The goal of the focused ultrasound treatment is to both lessen the main symptoms of Parkinson’s disease, which include tremors, rigidity and slow movement, as well as treat the dyskinesia that is a medication side effect, so that less medication is needed,” Howard M. Eisenberg, MD, the trial’s lead investigator, said in a press release.  Eisenberg is a professor and the chair of neurosurgery at both UMSOM and UMMC.

Participants are currently being recruited for the new trial (NCT03319485), which follows a previous study where MRI-guided focused ultrasound led to a 62% improvement in upper-limb tremors, compared with 22% in the control group, in patients with tremor-dominant Parkinson disease who did not respond to other forms of therapy.

Findings were published in the study, “Safety and Efficacy of Focused Ultrasound Thalamotomy for Patients With Medication-Refractory, Tremor-Dominant Parkinson Disease: A Randomized Clinical Trial,” in the journal JAMA Neurology.

“The results of the pilot trial, so far, are very encouraging,” said Eisenberg about the first trial conducted in 2015 with 20 patients, the majority of whom were treated at UMMC.

With the new technology, clinicians direct ultrasound waves to a brain structure called the globus pallidus, which helps regulate voluntary movement, to destroy damaged tissue, decreasing the uncontrolled movements that characterize Parkinson’s disease.

Doctors use magnetic resonance imaging (MRI) to create a temperature map of the brain, giving them a real-time picture of the region they want to hit with the sound waves. They then raise the energy, directly targeting that area of the brain to destroy the tissue.

Patients are awake and alert the entire time in the MRI scanner, enabling them to give clinicians constant feedback. They are fitted with a helmet through which the energy is converted into sound waves, which are then targeted to the globus pallidus. The approach is noninvasive, meaning there is no surgery or radiation treatment involved.

Current therapies to lessen movement and coordination problems in Parkinson’s patients include levodopa (sold under the brand name Dopar, among others), which is the most common. Patients with advanced Parkinson’s may undergo surgery, known as deep brain stimulation, to implant micro-electrodes in the brain that help control tremors, rigidity and dyskinesia (abnormal, uncontrolled, involuntary movement).

“For people with Parkinson’s disease and other movement disorders such as essential tremor, focused ultrasound is an appealing alternative to deep brain stimulation because it does not involve more invasive surgery,” said Paul S. Fishman, MD, PhD, professor of neurology at UMSOM and a neurologist at UMMC.

Enrollment in the study is approximately 80 to 100 participants, and the inclusion criteria were designed to include a wider population of Parkinson’s patients. Sponsored by InSightec, the trial is recruiting participants in the U.S. at the University of Maryland Medical System, Maryland; Weill Cornell Medicine, New York; and The Ohio State Wexner Medical Center, Ohio.

“University of Maryland Medicine is a world leader in pioneering MRI-guided focused ultrasound to become a new standard of care for treating many devastating brain diseases including Parkinson’s, essential tremor and glioblastoma, an often deadly type of brain cancer,” said E. Albert Reece, MD, PhD, MBA, vice president of medical affairs at the University of Maryland and dean of UMSOM.

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Source: Parkinson's News Today