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Deep Brain Stimulation Adjustments for Parkinson's Disease (FREQUENCY Trial)
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Waitlist Available
Led By Darlene Floden, PhD
Research Sponsored by Darlene Floden
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist
Disease duration of at least 4 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-60 minutes after stimulation adjustment
Awards & highlights
FREQUENCY Trial Summary
This trial looks at how different locations and frequencies of electrical stimulation to the subthalamic nucleus (a deep brain structure) affects cognition in Parkinson's patients who have had deep brain stimulation surgery.
Who is the study for?
This trial is for Parkinson's patients aged 40-70 who've had Deep Brain Stimulation (DBS) for at least 3 months. They must be diagnosed by a specialist, have had the disease for over 4 years, and can consent to participate. Those with previous brain surgeries for PD, other CNS diseases, severe psychiatric symptoms or dementia, substance abuse issues, or sensory impairments that affect testing cannot join.Check my eligibility
What is being tested?
The study is looking into how changing the location and frequency of stimulation in the subthalamic nucleus affects cognitive functions in Parkinson's patients with DBS implants. It aims to personalize DBS settings to improve non-motor symptoms.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include changes in mood or cognition due to adjustments in DBS parameters. There could also be risks associated with undergoing additional MRI scans if required by the study.
FREQUENCY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Parkinson's disease by a specialist.
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My condition has been diagnosed for over 4 years.
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I am between 40 and 70 years old.
FREQUENCY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-60 minutes after stimulation adjustment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-60 minutes after stimulation adjustment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Finger tapping speed
Reaction time
Verbal Fluency
FREQUENCY Trial Design
1Treatment groups
Experimental Treatment
Group I: Personalized DBS adjustmentsExperimental Treatment1 Intervention
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
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Who is running the clinical trial?
Darlene FlodenLead Sponsor
Darlene Floden, PhDPrincipal InvestigatorThe Cleveland Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had brain surgery for Parkinson's disease.I have been diagnosed with Parkinson's disease by a specialist.I have a history of brain or nerve diseases, not including migraines.You have significant mental health symptoms that meet specific criteria in a diagnostic manual, except for mild depression.I have had deep brain stimulation in both sides of my brain for over 3 months.My condition has been diagnosed for over 4 years.I am between 40 and 70 years old.You have been diagnosed with severe memory and thinking problems by a specialist.You currently abuse alcohol or drugs.You have trouble hearing or seeing that makes it difficult for you to take a test of your thinking skills.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized DBS adjustments
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.
Are participants still being sought for this investigation?
"According to clinicaltrials.gov, the recruitment period for this medical trial has concluded and it is no longer actively seeking participants. Although the initial post was published on May 30th 2018, with a subsequent update occurring on August 30th 2022, there are still 490 other trials accepting patients at present."
Answered by AI
Is the eligibility criteria inclusive of individuals aged 25 or older for this clinical research?
"The necessary qualifications for participation in this trial state that individuals must be between 40 to 70 years old. Additionally, there are 27 studies recruiting people under 18 and 487 for those over 65."
Answered by AI
What criteria must one meet to be a viable participant in this trial?
"This study is searching for 15 volunteers, between the ages of 40 and 70, with Parkinson's disease that has been present in their body for at least 4 years."
Answered by AI
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