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Virtual Deep Brain Stimulation Management for Parkinson's Disease (ROAM-DBS Trial)
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.
ROAM-DBS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowROAM-DBS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ROAM-DBS Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Virtual Clinic Cohort
- Group 2: In-Clinic Cohort
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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