What side effects are associated with this type of intervention?

The most common treatments for Parkinson's Disease include levodopa, dopamine agonists (DAs), and Deep Brain Stimulation (DBS). Levodopa can cause nausea, somnolence, dizziness, headache, confusion, hallucinations, delusions, agitation, psychosis, and orthostatic hypotension. Dopamine agonists may lead to compulsive behaviors, including compulsive dopaminergic drug use, especially when used with levodopa. Deep Brain Stimulation, while generally well-tolerated, can have side effects such as infection, bleeding, and hardware complications. Remote programming updates for DBS aim to optimize these treatments more efficiently, potentially reducing the time to achieve symptom improvement.

What prior FDA approvals exist?

FDA-approved treatments for Parkinson's Disease include dopaminergic drugs such as levodopa and dopamine agonists like ropinirole, which help manage motor symptoms. Additionally, deep brain stimulation (DBS) is an approved surgical treatment that can be optimized remotely to expedite patient improvement, as studied in trials like the Virtual Clinic sessions. These treatments aim to improve the quality of life for patients by managing symptoms more effectively.

What other types of research exist?

Promising alternatives to Virtual Clinic sessions for Parkinson's Disease patients include: 1) Wearable technology integrated with IoT for continuous monitoring and self-management, which can provide real-time data and feedback to both patients and healthcare providers. 2) Telemedicine platforms that offer synchronous and asynchronous rehabilitation services, allowing for personalized and flexible care. 3) Advanced deep brain stimulation (DBS) programming techniques that utilize machine learning algorithms to optimize settings more efficiently. These alternatives aim to enhance patient outcomes by leveraging technology for more precise and accessible care.

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Device

Virtual Deep Brain Stimulation Management for Parkinson's Disease (ROAM-DBS Trial)

N/A

Waitlist Available

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is over 21 years old

Subject is indicated for implant with an Infinity IPG for Parkinson's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3-months after initial programming visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if remote adjustments of brain stimulation settings can help patients faster than in-person visits. It focuses on patients with brain stimulation devices who are already receiving treatment. The remote system allows doctors to fine-tune settings over the internet.

Who is the study for?

This trial is for adults over 21 with Parkinson's Disease who are getting the Abbott Infinity DBS system implanted and haven't had a DBS before. They must be able to read, write, use the Virtual Clinic feature, have internet access for it, and not be in another study that could affect results.

What is being tested?

The ROAM-DBS study is testing if patients using the NeuroSphere Virtual Clinic can improve their symptoms faster than those only attending in-clinic sessions. It measures how quickly they feel a positive change after device programming adjustments.

What are the potential side effects?

While specific side effects aren't listed here, typical risks of Deep Brain Stimulation include infection at implant site, headache, confusion, speech problems and difficulty coordinating movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 21 years old.

Select...

I am recommended to get an Infinity IPG implant for Parkinson's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3-months after initial programming visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3-months after initial programming visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3-months after initial programming visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Endpoint: The time to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the initial programming visit

Primary Safety Endpoint: Rate of programming related adverse events for the Virtual Clinic cohort

Secondary study objectives

"On Time" (time each day without troublesome symptoms or side effects) (derived from Home Monitoring)

Clinical Global Impression (CGI)

Health care resource utilization: Number of hospitalizations and ER visits

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: In-Clinic CohortExperimental Treatment1 Intervention

Subjects who are implanted with Abbott Infinity DBS systems with the Neuosphere Virtual Clinic feature, and receive programming for their DBS system in-clinic only.

Group II: Virtual Clinic CohortActive Control1 Intervention

Subjects who are implanted with Abbott Infinity DBS systems with the Neuosphere Virtual Clinic feature, and receive programming for their DBS system with Virtual Clinic and in-clinic sessions.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) primarily aim to manage motor symptoms by enhancing dopaminergic activity. Levodopa, the most effective treatment, is converted to dopamine in the brain, replenishing the diminished neurotransmitter. Dopamine agonists mimic dopamine by stimulating dopamine receptors directly, while MAO-B inhibitors prevent the breakdown of dopamine, prolonging its action. Non-pharmacologic treatments like deep brain stimulation (DBS) involve implanting electrodes in specific brain areas to modulate neural activity. Remote programming updates for DBS, as studied in Virtual Clinic sessions, can expedite patient improvement by allowing timely and precise adjustments to the stimulation parameters, enhancing symptom control and overall quality of life for PD patients.

Current Management and Emerging Therapies in Multiple System Atrophy.Therapeutic strategies for nonmotor symptoms in early Parkinson's disease: the case for a higher priority and stronger evidence.