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Procedure
High-density Microelectrode for Parkinson's Disease
N/A
Waitlist Available
Led By Adam Mamelak, MD
Research Sponsored by Cedars-Sinai Medical Center
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 one week after recording in or completed
Awards & highlights
Study Summary
This trial tests a new electrode to measure brain nerve cells & local field potentials, to see if it works better than standard electrodes & is safe.
Who is the study for?
This trial is for adults over 18 with Parkinson's Disease who are undergoing a Deep Brain Stimulating (DBS) electrode implant in the brain to improve treatment. They must be able to consent and have no allergies to stainless steel or polyimide, nor previous DBS implants at the site.Check my eligibility
What is being tested?
The study tests a new high-density microelectrode designed for recording individual and group nerve cell activity in the human brain. It aims to compare its performance and safety against standard electrodes during DBS procedures.See study design
What are the potential side effects?
While specific side effects aren't listed, potential risks may include typical surgical complications related to DBS procedures such as infection, bleeding, or allergic reactions to materials used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one week after recording in or completed
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week after recording in or completed
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Breakage of Electrode
Neuronal Activity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neuronal Recording and Behavioral TestingExperimental Treatment1 Intervention
Neuronal Recording and Behavioral Testing
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Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,847 Total Patients Enrolled
Adam Mamelak, MDPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
264 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I can understand and agree to the study's details on my own.I am getting a DBS implant for Parkinson's to better locate the STN.
Research Study Groups:
This trial has the following groups:- Group 1: Neuronal Recording and Behavioral Testing
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period open for this clinical experiment?
"According to the information found on clinicaltrials.gov, enrollment in this medical study has been temporarily paused since June 22nd 2023. However, there are other 514 trials currently recruiting patients at present time."
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