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Deep Brain Stimulation
Deep Brain Stimulation for Parkinson's Disease
N/A
Recruiting
Led By Kiarash Shahlaie, MD, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system
Individuals who are 18 years and older
Must not have
Individuals unable to provide consent and/or lack capacity to consent
Individuals diagnosed with any cognitive or physical impairments that would limit their ability to participate in the cognitive testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, hour 24, week 1, month 1, month 2, month 4, and month 5
Awards & highlights
No Placebo-Only Group
Summary
This trialwill test if stimulating the brain with low frequency in Parkinson's patients can improve their cognitive control.
Who is the study for?
This trial is for adults with advanced Parkinson's Disease who have had a specific type of deep brain stimulation (DBS) surgery using the Boston Scientific VerciseTM system. They must be able to consent, participate in cognitive tests, and not have severe cognitive or physical impairments.
What is being tested?
The study is testing low frequency stimulation of the ventral STN alongside standard high frequency stimulation of the dorsal STN in patients with Parkinson's. It aims to see if this can improve cognition without worsening motor symptoms.
What are the potential side effects?
Potential side effects may include changes in mood or behavior, headache, dizziness, difficulty concentrating, and other neurological effects related to DBS adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Parkinson's and received a Boston Scientific Vercise DBS implant.
Select...
I am 18 years old or older.
Select...
I have advanced Parkinson's and underwent DBS surgery targeting the STN for motor improvement.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to give consent for myself.
Select...
I do not have cognitive or physical impairments that limit my participation in tests.
Select...
I am not fluent in English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, hour 24, week 1, month 1, month 2, month 4, and month 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, hour 24, week 1, month 1, month 2, month 4, and month 5
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change from Baseline in Cognitive Performance Scores on the Montreal Cognitive Assessment - Blind (MoCA)
Mean Change from Baseline in Depression Scores on the CES-D Short Version (CES-D-R10)
Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)
+4 moreSecondary study objectives
Mean Change from Baseline in Decision-Making Scores on Probabilistic Gambling Task
Mean Change from Baseline in Inter-Temporal Choice Scores on a Temporal Discounting Task
Mean Change from Baseline in Verbal Fluency Scores on Word Generation Task
Awards & 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: Sustained Dual Frequency, Dual Region, StimulationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep brain stimulation
2010
Completed Phase 3
~390
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
942 Previous Clinical Trials
4,755,665 Total Patients Enrolled
Kiarash Shahlaie, MD, PhDPrincipal InvestigatorUniversity of California, Davis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give consent for myself.I do not have cognitive or physical impairments that limit my participation in tests.I am not fluent in English.I have Parkinson's and received a Boston Scientific Vercise DBS implant.I am 18 years old or older.You have a high score on a test for depression.You have had the Boston Scientific VerciseTM DBS system implanted for at least 3 months.You are pregnant or in prison.I have advanced Parkinson's and underwent DBS surgery targeting the STN for motor improvement.You have a score lower than 15 on a specific cognitive test.
Research Study Groups:
This trial has the following groups:- Group 1: Sustained Dual Frequency, Dual Region, 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.
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