5 Participants NeededMy employer runs this trial

Deep Brain Stimulation for Parkinson's Disease

MD
Overseen ByMacKenzie Dunlap
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the connection between brain signals and walking and balance issues in people with Parkinson's disease. Researchers will test various settings of deep brain stimulation (DBS), a therapy that sends electrical impulses to specific brain areas, to assess their impact on symptoms like freezing of gait (sudden inability to move the feet). Participants will perform tasks such as walking in a virtual reality setting to simulate real-world challenges. Candidates for this trial include those with Parkinson's disease who already use a Medtronic Percept DBS device and experience freezing of gait. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving DBS therapy for Parkinson's.

What prior data suggests that deep brain stimulation is safe for Parkinson's disease patients?

Research has shown that deep brain stimulation (DBS) is generally safe for people with Parkinson's disease. One study found that DBS improved movement problems, such as tremors and stiffness, for many patients. However, some risks exist. The chance of permanent health issues, like bleeding in the brain, is about 1%. Serious events, including death, are rare but possible, as with any surgery.

Another study found that some patients experienced side effects, such as hallucinations and memory problems (dementia). Older individuals might face a higher risk of these issues. Despite these concerns, DBS remains a reliable and safe treatment option for Parkinson's, especially with careful management.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different deep brain stimulation (DBS) conditions can impact Parkinson's disease symptoms. Unlike standard DBS treatments, which typically use a single, clinically optimized setting, this approach allows for multiple DBS conditions to be tested within the same individual. This trial uniquely combines real-world virtual reality tasks with detailed recordings of brain and movement data, offering a deeper understanding of how DBS can be more effectively tailored to improve mobility and quality of life for those with Parkinson's.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

Research has shown that deep brain stimulation (DBS) can greatly improve movement problems in people with Parkinson's disease. In one study, patients' movement abilities improved by 53% after two years of DBS treatment. Another study found that 75% of participants felt DBS helped them manage their symptoms well. DBS has reduced shaking, stiffness, and other movement issues. It is commonly used in medical practice and is considered a key treatment for advanced Parkinson's disease. In this trial, participants will undergo multi-condition DBS assessments to explore various stimulation paradigms and their effects on movement and neural activity. These findings suggest DBS can be a powerful tool in managing Parkinson's disease symptoms.678910

Who Is on the Research Team?

JL

Jay L Alberts, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Parkinson's disease who experience balance problems or freezing while walking. Participants should be able to walk and may already have a deep brain stimulator implanted.

Inclusion Criteria

I experience sudden freezing when I try to walk.
Already have a Medtronic Percept DBS device implanted as part of medical care
DBS settings have been stable for at least 3 months
See 4 more

Exclusion Criteria

Currently have alcohol or substance abuse problems
Have hearing or vision problems that would make it difficult to use a virtual reality headset
Have any medical or mental health condition that would make it unsafe or difficult to participate in the opinion of the study doctor
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo baseline assessments without stimulation to establish control conditions

1 week
1 visit (in-person)

Treatment

Participants complete walking and balance tasks under multiple DBS conditions in a virtual reality environment

1 week
5 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait)
  • Moving Overground in a Virtual Environment (MOVE)
  • Multiple Deep Brain Stimulation (DBS) Conditions

Trial Overview

Researchers are studying how different settings of deep brain stimulation (DBS) affect walking and balance in Parkinson’s disease, using tasks like moving in virtual environments and stair-walking evaluations.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants With Parkinson Disease Undergoing Multi-Condition DBS AssessmentsExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Medtronic

Industry Sponsor

Trials
627
Recruited
767,000+
Geoff Martha profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Citations

DBS Outcomes | Brain Institute

For Parkinson's patients · Improved movement: One study found that patient motor scores improved 53% after two years with DBS, compared to improving 4% among ...

Deep Brain Stimulation: Success Rate for Parkinson's

The results showed that 75%Trusted Source of participants felt the procedure helped them manage their symptoms. Generally, researchTrusted ...

Consensus expert recommendations for referral of ...

Deep brain Stimulation (DBS) surgery effectively alleviates troublesome motor symptoms of Parkinson's disease (PD) such as tremor, rigidity, ...

Deep Brain Stimulation in Parkinson's Disease: Motor and ...

Objective: To compare motor outcomes (gait speed, balance, freezing of gait, fear of falling, muscle strength, functional capacity, and physical activity level) ...

The mortality of patients with Parkinson's disease with deep ...

Long-term outcome of 50 consecutive Parkinson's disease patients treated with subthalamic deep brain stimulation. Parkinsonism Relat Disord. (2008) 14:114–9 ...

Deep Brain Stimulation (DBS)

DBS improves quality of life for some people and can reduce tremor, stiffness, slowness, dyskinesia (involuntary movements) and fluctuations in movement control ...

Consensus Statements on Deep Brain Stimulation in ...

Deep brain stimulation (DBS) has become a cornerstone therapy for advanced Parkinson's disease (PD), consistently showing superior outcomes over ...

Benefits of Deep Brain Stimulation for Early Stage ...

Deep brain stimulation can lower disease progression risk in patients with early Parkinson disease compared with optimal medical therapy ...

Deep Brain Stimulation in Parkinson Disease: A Meta-analysis ...

They observed that dementia was present in 46% and hallucinations in 58% of the 79 PD patients. Furthermore, older age at surgery was correlated with an ...