DBS Settings Optimization for Parkinson's Disease
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Deep Brain Stimulation (DBS) for Parkinson's Disease?
Deep Brain Stimulation (DBS) has been shown to be a highly effective treatment for advanced Parkinson's disease, improving symptoms and quality of life. Studies highlight the importance of careful programming and patient selection to achieve the best results, and new techniques like 'Coordinated Reset' DBS are being explored to enhance its benefits.12345
Is deep brain stimulation (DBS) generally safe for humans?
Deep brain stimulation (DBS) is generally considered safe, but it can have complications. Common issues include infections, lead migrations (movement of the wires), and device malfunctions, with some cases requiring additional surgery. Serious complications like permanent neurological problems occur in 4-6% of cases.678910
How is Deep Brain Stimulation (DBS) different from other treatments for Parkinson's disease?
Deep Brain Stimulation (DBS) is unique because it involves implanting electrodes in the brain to send electrical impulses, which can help manage symptoms of Parkinson's disease by altering brain activity. Unlike medications that are taken orally, DBS is a surgical treatment that offers a reversible and adjustable option, allowing for personalized settings to optimize symptom control.111121314
What is the purpose of this trial?
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.
Eligibility Criteria
This trial is for Parkinson's Disease patients aged 18-85 with bilateral DBS implants, a cognitive score of at least 23, and who are at least 3 months post-implant. They must have had specific MRI and CT imaging done. Pregnant or nursing women, those with nearly depleted IPG batteries, inability to walk without stimulation, or gait issues not caused by PD cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo two different neurostimulator settings for two weeks to compare effects on Parkinson's symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of ADL and QOL scales
Treatment Details
Interventions
- Deep Brain Stimulation (DBS)
Deep Brain Stimulation (DBS) is already approved in United States, European Union, Canada for the following indications:
- Advanced Parkinson's disease
- Medically refractory tremor
- Dystonia
- Obsessive-compulsive disorder
- Parkinson's disease
- Essential tremor
- Dystonia
- Psychiatric conditions
- Parkinson's disease
- Essential tremor
- Dystonia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor