← Back to Search

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

ROAM-DBS Trial Summary

This trial is comparing the time it takes for patients to improve when they have in-person or virtual appointments with their doctor. They hope to show that virtual appointments help patients improve faster.

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.Check my eligibility
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.See study design
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.

ROAM-DBS Trial 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.

ROAM-DBS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
"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

ROAM-DBS 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.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
635 Previous Clinical Trials
405,135 Total Patients Enrolled
Marie FaheyStudy DirectorAbbott Medical Devices Neuromodulation
4 Previous Clinical Trials
1,571 Total Patients Enrolled
Devyani NanduriStudy DirectorAbbott Medical Devices Neuromodulation
2 Previous Clinical Trials
3,000 Total Patients Enrolled

Media Library

Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05269862 — N/A
Parkinson's Disease Research Study Groups: Virtual Clinic Cohort, In-Clinic Cohort
Parkinson's Disease Clinical Trial 2023: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature Highlights & Side Effects. Trial Name: NCT05269862 — N/A
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269862 — N/A

Frequently Asked Questions

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

What is the primary objective of this research project?

"According to Abbott Medical Devices, the main outcome measured over a 3-month period will be Patient's Global Impression of Change (PGIC). Furthermore, Levodopa Equivalent Dose (LED), Patient Global Impression (PGI), and Clinical Global Impression (CGI) scores will also be compared between virtual Clinic cohort and in-clinic cohorts."

Answered by AI

Is enrollment currently available for this experiment?

"Affirmative. According to the records on clinicaltrials.gov, this trial commencing March 24th 2022 is still seeking applications for participants. The most recent update was posted November 2nd 2022."

Answered by AI

What is the enrollment size of this investigation?

"Affirmative, the details posted on clinicaltrials.gov confirm that this medical experiment is presently recruiting volunteers. Initially announced on March 24th 2022 and recently updated on November 2nd 2022, 100 participants are desired from 11 various health facilities."

Answered by AI

Is this trial being administered in a multitude of Canadian healthcare facilities?

"Patients seeking to enrol in this trial can do so at one of 15 sites. University of Miami Hospital, University of Arizona Health Sciences Center and Beth Israel Deaconess Medical Center are three notable centres located in Florida, Arizona and Massachusetts respectively."

Answered by AI
~33 spots leftby Mar 2025