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Deep Brain Stimulation for Cognitive Impairment in Parkinson's Disease
N/A
Recruiting
Research Sponsored by Vanderbilt University 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 baseline to end of deep brain stimulation (dbs), approximately 3-4 hours
Awards & highlights
Study Summary
This trial looks at how Deep Brain Stimulation affects thinking in Parkinson's Disease patients to develop ways to minimize its side effects. #Neurology #ParkinsonsDisease #DeepBrainStimulation
Who is the study for?
This trial is for adults over 18 with Parkinson's Disease who are scheduled for or have already undergone Deep Brain Stimulation (DBS) surgery at Vanderbilt University Medical Center. Participants must be able to engage in testing during the operation, speak English, and have a DBS system that can record brain activity.Check my eligibility
What is being tested?
The study is examining how DBS might affect thinking skills in Parkinson's patients by looking for patterns in brain signals recorded during and after surgery. The goal is to use these 'biomarkers' to improve where electrodes are placed and how they're programmed.See study design
What are the potential side effects?
While this study focuses on recording brain activity rather than drug effects, potential side effects may include those typically associated with DBS surgery such as headache, confusion, speech problems, or difficulty coordinating movements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of deep brain stimulation (dbs), approximately 3-4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of deep brain stimulation (dbs), approximately 3-4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting
Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation
Trial Design
2Treatment groups
Experimental Treatment
Group I: Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulationExperimental Treatment1 Intervention
Neurophysiology recordings will be performed from subthalamic nucleus (STN) or globus pallidus internus (GPI) with stimulation on and off, at rest and during a working memory task, in patients who have previously been implanted with DBS and have implantable pulse generators capable of recording local field potentials.
Group II: Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairmentExperimental Treatment1 Intervention
Neurophysiology recordings will be performed from dorsolateral prefrontal cortex (DLPFC) during deep brain stimulation surgery, with and without STN or GPI stimulation, at rest and during a working memory task.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,033 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I am unable to follow instructions or directions during surgery.I can undergo tests during surgery.I am 18 years old or older.I have been diagnosed with Parkinson's disease by a specialist.I am scheduled for deep brain stimulation surgery at Vanderbilt under local anesthesia.
Research Study Groups:
This trial has the following groups:- Group 1: Determination of DLPFC neurophysiology biomarkers of DBS associated cognitive impairment
- Group 2: Neurophysiology biomarkers of DBS mediated cognitive impairment following chronic stimulation
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 this research endeavor currently open to recruitment?
"Affirmative. Data posted on clinicaltrials.gov confirms that this medical trial, which was first published on July 1st 2023, is actively seeking recruits. The study requires 160 participants to enroll from one site."
Answered by AI
How many individuals are engaged in this medical research endeavor?
"Affirmative. The information found on clinicaltrials.gov states that this investigation, which was initially posted in July of 2023, is actively enrolling patients. 160 individuals are required to be recruited from one site."
Answered by AI
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