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Procedure

Deep Brain Stimulation Adjustments for Parkinson's Disease (FREQUENCY Trial)

N/A
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
Must not have
History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
History of other central nervous system disease (excluding migraine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-60 minutes after stimulation adjustment
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had brain surgery for Parkinson's disease.
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I have a history of brain or nerve diseases, not including migraines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-60 minutes after stimulation adjustment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-60 minutes after stimulation adjustment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Finger tapping speed
Reaction time
Verbal Fluency

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: Personalized DBS adjustmentsExperimental Treatment1 Intervention
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Find a Location

Who is running the clinical trial?

Darlene FlodenLead Sponsor
Darlene Floden, PhDPrincipal InvestigatorThe Cleveland Clinic

Media Library

Personalized DBS adjustments (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03800108 — N/A
Parkinson's Disease Research Study Groups: Personalized DBS adjustments
Parkinson's Disease Clinical Trial 2023: Personalized DBS adjustments Highlights & Side Effects. Trial Name: NCT03800108 — N/A
Personalized DBS adjustments (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03800108 — N/A
~2 spots leftby Sep 2025
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