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Neurostimulation

Neurostimulation for Parkinson's Disease

N/A
Waitlist Available
Led By Clete Kushida, MD, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absence of abnormalities on brain MRI suggestive of an alternate diagnosis or serving as a contraindication to surgery
Age 21 - 80 years
Must not have
Prior intracranial surgery
Coagulopathy, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years 1-2
Awards & highlights
No Placebo-Only Group

Summary

This trialwill study Parkinson's disease and sleep dysfunction, exploring ways to manipulate brain signals to improve sleep. #PD #Parkinsons #Sleep #DBS #DeepBrainStimulation

Who is the study for?
This trial is for adults aged 21-80 with Parkinson's Disease (PD) who have severe motor symptoms not adequately managed by medication, and are candidates for deep brain stimulation surgery. They must have had PD motor symptoms for at least 4 years, no significant cognitive deficits or depression, and no history of certain medical conditions like seizures or heart disease.
What is being tested?
The study tests if subthalamic nucleus oscillations can be linked to sleep stages in PD patients and whether adaptive neurostimulation can increase restorative sleep. It uses advanced DBS technology to identify sleep biomarkers and create stimulation patterns that adapt to ongoing sleep-stage changes.
What are the potential side effects?
While the specific side effects are not listed here, typical risks may include those associated with deep brain stimulation such as infection risk at the surgical site, headache, confusion or difficulty concentrating, speech problems, balance issues, and tingling or prickling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain MRI does not show any issues that would prevent surgery.
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I am between 21 and 80 years old.
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My movement symptoms are severe and need surgery despite medication.

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 before.
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I do not have uncontrolled blood pressure, bleeding disorders, seizures, heart disease, or issues with anesthesia.
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I am currently receiving ECT, rTMS, or diathermy treatments.
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I have Restless Leg Syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~years 1-2
This trial's timeline: 3 weeks for screening, Varies for treatment, and years 1-2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep stage duration and transitions
Secondary study objectives
Sleep Quality

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: PD with DBSExperimental Treatment1 Intervention
Patients with Parkinson's Disease who opt for DBS surgery and consent to participate in the sleep study.

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,364 Total Patients Enrolled
Stanford UniversityOTHER
2,472 Previous Clinical Trials
17,501,798 Total Patients Enrolled
University of Colorado, DenverOTHER
1,805 Previous Clinical Trials
2,822,326 Total Patients Enrolled

Media Library

Sub-clinical stimulation (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04620551 — N/A
Parkinson's Disease Research Study Groups: PD with DBS
Parkinson's Disease Clinical Trial 2023: Sub-clinical stimulation Highlights & Side Effects. Trial Name: NCT04620551 — N/A
Sub-clinical stimulation (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04620551 — N/A
~2 spots leftby Jun 2025
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