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Deep Brain Stimulation
DBS for Parkinson's Disease (DBS + FOG Trial)
N/A
Recruiting
Led By Jonathan R Jagid, MD
Research Sponsored by Jonathan Jagid
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether DBS can help people with Parkinson's disease who have severe freezing of gait.
Who is the study for?
This trial is for Parkinson's Disease patients aged 40-75 with severe freezing of gait that doesn't get better with Levodopa. They should have minimal other symptoms or those well controlled by medication or existing DBS, and no major cognitive issues, depression, medical co-morbidities, incompatible implants, drug use (except medicinal marijuana), pregnancy/breastfeeding intentions, prior brain surgery or investigational drugs.
What is being tested?
The study tests if the Vercise DBS System can safely and effectively treat severe freezing of gait in Parkinson's patients who don't respond to Levodopa. Participants will undergo deep brain stimulation targeting the cuneiform nucleus to see if it improves their condition.
What are the potential side effects?
While not specified here, typical side effects of DBS may include headache, confusion, difficulty concentrating, stroke-like symptoms such as weakness or numbness on one side of the body; changes in mood or behavior; seizures; hardware complications like lead migration; infection at implant site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent Change in Gait Velocity
Percent change in UPDRS Part III on/off stimulation
Secondary study objectives
Percent Change in FOG Questionnaire
Percent Change in Muscle Amplitude
Percent Change in PDQ 39
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Vercise DBS GroupExperimental Treatment1 Intervention
All participants will have the Vercise DBS system implanted.
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Who is running the clinical trial?
Jonathan JagidLead Sponsor
2 Previous Clinical Trials
5 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
744 Previous Clinical Trials
857,819 Total Patients Enrolled
Jonathan R Jagid, MDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
4 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate if you need certain medical procedures like diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT).If you are currently breastfeeding, you cannot participate in the study.If you have Parkinson's disease and experience severe difficulty with walking and balance, as well as freezing of movement, you may be excluded from the study.You are between 40 and 75 years old and have shown significant improvement in your symptoms with Levodopa medication.You have mild symptoms of tremors, slow movements, and stiffness, or your symptoms are well managed with medication or a brain implant called DBS.You have previously had surgery inside your head.You have other conditions that affect your thinking and memory abilities.You are currently taking experimental drugs or any other treatments that are not recommended for Parkinson's Disease management.a) Your symptoms of tremors, slow movement, and stiffness are well controlled with medication (Levodopa), so you may not be a good candidate for a specific type of surgical treatment called deep brain stimulation (DBS).
b) If you have already had DBS surgery and you still have significant problems with balance and walking that do not respond to Levodopa, you may be excluded from the study.
Research Study Groups:
This trial has the following groups:- Group 1: Vercise DBS Group
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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