← Back to Search

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

DBS + FOG Trial 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.Check my eligibility

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.See study design

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.

DBS + FOG Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percent Change in Gait Velocity

Percent change in UPDRS Part III on/off stimulation

Secondary outcome measures

Percent Change in FOG Questionnaire

Percent Change in Muscle Amplitude

Percent Change in PDQ 39

+2 more

DBS + FOG Trial Design

1Treatment groups

Experimental Treatment

Group I: Vercise DBS GroupExperimental Treatment1 Intervention

All participants will have the Vercise DBS system implanted.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jonathan JagidLead Sponsor

2 Previous Clinical Trials

5 Total Patients Enrolled

Boston Scientific CorporationIndustry Sponsor

720 Previous Clinical Trials

933,018 Total Patients Enrolled

Jonathan R Jagid, MDPrincipal InvestigatorUniversity of Miami

1 Previous Clinical Trials

1 Total Patients Enrolled

Media Library

Vercise DBS System (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04218526 — N/A

Parkinson's Disease Research Study Groups: Vercise DBS Group

Parkinson's Disease Clinical Trial 2023: Vercise DBS System Highlights & Side Effects. Trial Name: NCT04218526 — N/A

Vercise DBS System (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04218526 — N/A

Frequently Asked Questions

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

Is there availability for any participants to join this experimental research?

"Affirmative. Clinicaltrials.gov reveals that this investigation is actively seeking volunteers; the trial was first listed on April 27th 2020, with a recent update occurring on August 10th 2022. 4 participants are needed across one research centre."

Answered by AI

How many participants have been enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov reflects that this experiment, initially shared on April 27th 2020 and recently updated on August 10th 2022, is actively recruiting participants. The team requires 4 individuals to be recruited from a single medical centre."

Answered by AI

What is the ambition of this clinical experiment?

"According to Boston Scientific Corporation, the main metric measured during this trial is Percent change in UPDRS Part III on/off stimulation. The evaluation will take place at Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op intervals. Secondary objectives include assessing Percent Change in FOG Questionnaire (0-24 with higher score representing more severe freezing of gait), PDQ-L (37 items ranging from 0 - 185 with greater scores indicating poorer quality of life) and also tracking changes in number of Falls (Percentage shift unrelated to freezing)."

Answered by AI

Does my medical profile satisfy the criteria necessary to qualify for this trial?

"This clinical investigation is seeking 4 individuals with Parkinson's disease who are between 40 and 75 years old."

Answered by AI

Is it a requirement for participants to be younger than fifty-five years of age?

"This medical trial is available to adults between the ages of 40 and 75. Those under 18 or over 65 can seek out 27 different trials, while 485 other studies are accessible for seniors."

Answered by AI