Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature for Parkinson Disease
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
See full descriptionAbout the trial for Parkinson Disease
Treatment Groups
This trial involves 2 different treatments. Abbott Infinity DBS Systems With The NeuroSphere Virtual Clinic Feature is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature will improve 2 primary outcomes and 10 secondary outcomes in patients with Parkinson Disease. Measurement will happen over the course of At 1 Year after initial programming visit.
Patient Q & A Section
What are common treatments for parkinson disease?
Many of the common PD therapies have modest evidence of effectiveness. There exists a large gap between the evidence supporting the usefulness of treatments for PD and the number of people with PD receiving treatment.
Can parkinson disease be cured?
A cure for PD is not possible. Clinical and electrophysiological criteria for 'cure' are hard to define. A cure is possible only for a minority of patients; many never achieve a cure. Long-term follow up is needed to confirm if some patients may experience long-term remission.
What is parkinson disease?
Parkinson disease (PD) is a neurodegenerative disorder characterized by a gradual depletion of dopamine-producing cells in the nigrostriatal region. Symptoms develop most commonly around the age of 70 and include muscle stiffness, resting tremor, difficulty with balance, swallowing, and slowness of movement. Most people with PD develop a disabling condition called Parkinsonian gait disease after about 5 years. Older people with PD are also at risk of developing cognitive and behavioral changes and sleep problems.
How many people get parkinson disease a year in the United States?
An estimated 1.4 million people in the United States are diagnosed with Parkinson's disease each year. Among men, the rate is higher than among women, but that difference disappears in the older population (over age 80). Both men and women in that population are more likely to be diagnosed with the more prevalent form of the disease, Parkinson's disease with dementia than with Parkinson's disease without dementia.
What are the signs of parkinson disease?
Neurological symptoms of PD are common during the early stages of disease. The most common clinical and radiological finding are tremor and bradykinesia. However, there can be overlap of symptoms due to other conditions, and so patients with PD should be carefully assessed to diagnose or rule out their condition. In more advanced stages of the disease, extrapyramidal symptoms such as rigidity, tremor and bradykinesia can predominate leading to the clinical diagnosis of PD.
What causes parkinson disease?
We found no evidence for a link between the risk of parkinson disease and certain occupational factors, such as cigarette smoking or exposure to pesticides. However, as in all epidemiological studies, the magnitude of the association was modest, with small effect modifications that needed further investigation, including studies of genetic and neurological risk factors.
Is abbott infinity dbs systems with the neurosphere virtual clinic feature safe for people?
Despite the limited and inconclusive data presented by this study, this preliminary evidence suggests that Abbott Infinity DBS does have a potential benefit for selected patients and could be considered as a treatment for certain subgroup of patients.
How serious can parkinson disease be?
The severity of PD depends on factors other than the PD disease progress, including age and gender. Therefore, assessing the seriousness and estimating the treatment needs, a lot more comprehensive study is needed to evaluate the seriousness and the optimal management methods in PD patients.
Has abbott infinity dbs systems with the neurosphere virtual clinic feature proven to be more effective than a placebo?
The Abbott Infinity DBS virtual clinic demonstrates significant, statistically significant improvement in clinical outcome compared to a placebo. Because no other type of treatment of the DBS has been found comparable in a placebo-controlled study design (although a type 1 open-label clinical trial comparing other neurosurgeries for people with severe, refractory tremors in the UK is underway), the Abbott Infinity DBS virtual clinic may have a role in the future treatment of DBS.
Is abbott infinity dbs systems with the neurosphere virtual clinic feature typically used in combination with any other treatments?
The Abbott VDBS and NSCS are typically combined with other treatments. However, both VDBS-only and NSCS-only patients derive similar long-term benefits with the abbott VDBS and NSCS, such as a good motor and cognitive functional outcome, and could be candidates to be treated without other treatments.
What is abbott infinity dbs systems with the neurosphere virtual clinic feature?
The neurosphere virtual clinic feature was found to be effective in educating and facilitating patient-initiated clinical trials at all three study sites. A potential limitation of the neurosphere virtual clinic feature is that its user interface is somewhat cumbersome. Additional work is needed to optimize and increase user and clinician compliance with using the neurosphere virtual clinic feature as part of a patient-initiated clinical trial.
How does abbott infinity dbs systems with the neurosphere virtual clinic feature work?
A significant improvement in efficiency was observed with a new neurosphere feature of Abbott Infinity DBS technology. As a result, a substantial savings was achieved by eliminating the manual component of this complex neurosphere feature.