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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ years 1-2

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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

555 Previous Clinical Trials

1,145,365 Total Patients Enrolled

Stanford UniversityOTHER

2,484 Previous Clinical Trials

17,516,101 Total Patients Enrolled

University of Colorado, DenverOTHER

1,809 Previous Clinical Trials

2,822,238 Total Patients Enrolled

University of PennsylvaniaOTHER

2,082 Previous Clinical Trials

42,726,692 Total Patients Enrolled

Clete Kushida, MD, PhDPrincipal InvestigatorStanford University

Casey Halpern, MDPrincipal InvestigatorStanford University

John Thompson, PhDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

336 Total Patients Enrolled

Aviva Abosch, MD, PhD2.76 ReviewsStudy Director - University of Nebraska

University of Nebraska

3 Previous Clinical Trials

91 Total Patients Enrolled

5Patient Review

I had a lobectomy done in April 17, 2014. I was in great care by Dr. Abosch and staff for the 21 days I was in the hospital. Everything leading up to my surgery was explained to me thoroughly so that I understood what all was being done. I will never forget how well not only myself was cared for but also my husband for being there with me. I often wonder to this day what Dr. Abosch and her team has learned from my right temporal lobe by chopping it up. I still think it would of made a cool night light or just give someone a piece of my mind. To this