CLINICAL TRIAL

Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature for Parkinson Disease

Recruiting · 18+ · All Sexes · Sevilla, Spain

Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

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About 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature
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Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
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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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subject is a participant in the ADROIT study.
Subject is over 21 years old.
Subject is able to read and write.
You have Parkinson's disease. show original
Subject has not previously been implanted with a DBS system.
The treating physician believes Virtual Clinic is appropriate as a component in the treatment regime for this subject. show original
You must provide written informed consent prior to any study-related procedure. show original
The patient will have access to the Abbott Virtual Clinic system. show original
Subject will have internet access on their Patient Controller in a location suitable for a Virtual Clinic session. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At 3-months after initial programming visit
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At 3-months after initial programming visit.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Levodopa Equivalent Dose (LED)
AT 1 YEAR AFTER INITIAL PROGRAMMING VISIT
LED will be assessed and the values of virtual Clinic cohort will be compared to that of in-clinic cohort.
Health care resource utilization: Number of hospitalizations and ER visits
AT 1 YEAR AFTER INITIAL PROGRAMMING VISIT
The number of hospitalizations and ER visits will be assessed
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
AT 1 YEAR AFTER INITIAL PROGRAMMING VISIT
MDS-UPDRS questionnaire is a widely used validated questionnaire to assess the severity of Parkinson's disease. This questionnaire is composed of four sections, however, this study shall only utilize part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms. The clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.
Parkinson's Disease Questionnaire (PDQ-39)
AT 1 YEAR AFTER INITIAL PROGRAMMING VISIT
PDQ-39 questionnaire is a widely used validated questionnaire to measure PD-specific health status (16-17). The self-administered questionnaire consists of 39 questions and assesses how often the subject has experienced difficulties during the past month due to PD across 8 dimensions including mobility, activities of daily living, emotional well-being, social support, cognition, communication and bodily discomfort. Each question is rated on a 5-point ordinal scoring system ranging from 0=never to 4=always. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). The overall score is expressed by a Summary Index. Lower scores reflect better quality of life. The clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.
Patient Global Impression (PGI)
AT 1 YEAR AFTER INITIAL PROGRAMMING VISIT
The PGI consists of 2 subscales, the first rating the severity of illness (PGIS) and the second evaluating the change in illness relative to a previous status (PGIC). The PGI scale evaluates all aspects of health and assesses if there has been an improvement or decline in clinical status. The scale consists of two items, one scale rating severity of illness and one rating global improvement. Severity is rated from 1=normal/not at all ill to 7= extremely ill. Global improvement is rated from 1=very much improved to 7=very much worse. The clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.
Clinical Global Impression (CGI)
AT 1 YEAR AFTER INITIAL PROGRAMMING VISIT
The CGI questionnaire is widely used for assessing symptoms and consists of two subscales, one rating severity of illness (CGIS) and one rating global improvement (CGIC) (12-14). Severity is rated from 1 = normal/not at all ill to 7 = among the most extremely ill. Global improvement is rated from 1 = very much improved to 7 = very much worse. The clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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