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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
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 belowSelect...
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
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 moreTrial 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.
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.
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.
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
649 Previous Clinical Trials
410,947 Total Patients Enrolled
Marie FaheyStudy DirectorAbbott Medical Devices Neuromodulation
4 Previous Clinical Trials
1,571 Total Patients Enrolled
Devyani NanduriStudy DirectorAbbott Medical Devices Neuromodulation
3 Previous Clinical Trials
3,126 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor thinks the wrong placement of DBS leads won't help me.I am over 21 years old.I am recommended to get an Infinity IPG implant for Parkinson's.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Clinic Cohort
- Group 2: In-Clinic Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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