Neurostimulation for Parkinson's Disease

Not currently recruiting at 4 trial locations

Overseen By Andrew Schnaubelt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Hypertension, Heart disease, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve sleep problems in people with Parkinson's disease (PD) using a special brain stimulation technique called sub-clinical stimulation. It focuses on individuals who already have deep brain stimulation (DBS) for movement issues and struggle with sleep. Researchers aim to determine if adjusting brain signals can enhance sleep quality. This trial might suit someone with PD who has severe motor symptoms that haven't improved with medication and is considering DBS surgery. As an unphased trial, it offers a unique opportunity to explore innovative treatments for sleep issues in PD patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that your motor symptoms should be severe enough despite optimized medical therapy, suggesting you may continue your current Parkinson's medications.

What prior data suggests that this neurostimulation technique is safe for Parkinson's disease patients?

Studies have shown that deep brain stimulation of the subthalamic nucleus (STN-DBS) is generally safe and well-tolerated for people with Parkinson's disease. This treatment has been used for some time, and research indicates it helps manage symptoms over the long term. Most recipients experience positive outcomes with few serious side effects. While every treatment carries some risks, evidence supports STN-DBS as a reliable option for managing Parkinson’s symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about sub-clinical stimulation for Parkinson's Disease because it offers a novel approach compared to traditional treatments like medication and conventional deep brain stimulation (DBS). Unlike standard DBS, which continuously delivers high-level electrical pulses, sub-clinical stimulation uses lower, targeted signals that may reduce side effects while maintaining or even enhancing effectiveness. This method holds promise for improving patients' quality of life by potentially minimizing complications like speech and balance issues often associated with higher-intensity DBS.

What evidence suggests that sub-clinical stimulation is effective for sleep dysfunction in Parkinson's disease?

Research has shown that Subthalamic Nucleus Deep Brain Stimulation (STN-DBS) can improve sleep problems in people with Parkinson's Disease. In this trial, participants with Parkinson's Disease who choose DBS surgery and consent to the sleep study will receive this treatment. Studies have found that STN-DBS not only aids movement issues but also has lasting positive effects on sleep, even as the disease progresses. This treatment targets brain areas that control sleep, potentially increasing time spent in restful sleep stages. This approach offers a promising solution for those with sleep issues in Parkinson's, beyond traditional sleep medications. ^{1 4 6 7 8}

Who Is on the Research Team?

Casey Halpern, MD

Principal Investigator

Stanford University

Clete Kushida, MD, PhD

Principal Investigator

Stanford University

John Thompson, PhD

Principal Investigator

University of Colorado, Denver

Aviva Abosch, MD, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My Parkinson's symptoms improve by at least 30% with medication, or I have significant, treatment-resistant tremor.

Ability to provide informed consent for this study

My Parkinson's symptoms haven't improved with oral medications.

Exclusion Criteria

I have had brain surgery before.

Pre-existing implanted stimulation system (e.g., cochlear implant, cardiac pacemaker, defibrillator, neuro-stimulator for indication other than Parkinson's disease) or ferromagnetic metallic implant

I do not have uncontrolled blood pressure, bleeding disorders, seizures, heart disease, or issues with anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo standard-of-care STN DBS lead implantation surgery for the treatment of PD

3 weeks

1 visit (in-person)

In-patient Sleep Lab

Participants return for 3 nights of STN LFP recordings with concurrent PSG, EMG, EOG, actigraphy, and video-EEG to establish a physiological sleep baseline and test sub-clinical stimulation

1 week

3 visits (in-patient)

Adaptive Stimulation Implementation

Implementation of adaptive stimulation algorithm developed in Aim 1 during nighttime sleep over 3 weeks of in-home sleep

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after adaptive stimulation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sub-clinical stimulation

Trial Overview

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.

How Is the Trial Designed?

Group I: PD with DBS Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In a study of 26 elderly patients with Parkinson's disease undergoing subthalamic deep brain stimulation (STN-DBS), there was a higher incidence of serious adverse events, particularly psychosis and hallucinations, compared to younger patients from the EARLYSTIM study.

Despite these psychiatric complications being transient, the overall benefits of STN-DBS in improving Parkinson's symptoms were found to outweigh the risks, highlighting the importance of thorough psychiatric evaluations before and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Candidates for Subthalamic Deep Brain Stimulation in Parkinson's Disease Have a Higher Incidence of Psychiatric Serious Adverse Events. Cozac, VV., Ehrensperger, MM., Gschwandtner, U., et al.[2020]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

In a study of 233 Parkinson's Disease patients who underwent Deep Brain Stimulation (DBS) of the subthalamic nucleus, only 11.76% of procedures resulted in surgical adverse events (SAEs), indicating a relatively low risk associated with the procedure.

Most SAEs were reversible, with only two cases leading to long-term effects, demonstrating that STN DBS is a safe surgical option with a high reliability rate of 95.59% for correct lead implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical adverse events of deep brain stimulation in the subthalamic nucleus of patients with Parkinson's disease. The learning curve and the pitfalls. Seijo, F., Alvarez de Eulate Beramendi, S., Santamarta Liébana, E., et al.[2022]

Subthalamic nucleus deep brain stimulation (STN DBS) is an effective treatment for both younger (<65 years) and older (≥65 years) patients with Parkinson's disease, showing significant improvements in motor function and medication dosage after 6 months.

While STN DBS is generally safe, older patients experienced a higher rate of complications (11.8%) compared to younger patients (2.6%), suggesting that careful consideration is needed when selecting older patients for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral subthalamic deep brain stimulation is an effective and safe treatment option for the older patients with Parkinson's disease. Kim, M., Cho, KR., Park, JH., et al.[2019]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8721829/

Subthalamic Nucleus Stimulation in Parkinson's Disease

STN‐DBS offers good long‐term effects, including improved sleep, despite disease progression. STN‐DBS surgery may negatively impact verbal fluency and ...

2.

nature.com

nature.com/articles/s41531-025-01124-7

Chronic adaptive deep brain stimulation for Parkinson's ...

With aDBS, we were able to increase the frequency to the standard 125 Hz, achieving better tremor control while also reducing dyskinesia ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2590112524000446

Single-center experience of utilization and clinical efficacy ...

This retrospective study covering a longitudinal period of up to 7 years compares the efficacy of segmented and non-segmented leads in motor symptom alleviation ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37700176/

Long-term safety and efficacy of frameless subthalamic ...

Our data support the use of the frameless system for STN-DBS in PD patients, as a safe and well-tolerated technique, with long-term clinical benefits and ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT02022735?tab=results

Deep Brain Stimulation Effects on Gait and Balance in ...

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06498349

Bilateral Subthalamic Stimulation in PD Patients With ...

The focus of the study is on patients Parkinson's disease showing as well behavioral disorders that can be described as pathological and are summarized ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10791817/

Long-term safety and efficacy of frameless subthalamic deep ...

Our data support the use of the frameless system for STN-DBS in PD patients, as a safe and well-tolerated technique, with long-term clinical benefits and ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02231645

Subthalamic Deep Brain Stimulation Effects on Decision ...

The purpose of this study is to evaluate whether subthalamic deep brain stimulation (STN DBS) can affect moral and economic decisions in patients with ...