Personalized Real-Time Deep Brain Stimulation for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a personalized treatment for people with Parkinson's disease using deep brain stimulation (DBS). The researchers aim to determine how real-time control of brain activity can help manage Parkinson's symptoms. Participants will receive different types of DBS, with some treatments amplifying and others suppressing brain signals, alongside traditional medication such as Carbidopa/Levodopa. This trial suits those diagnosed with Parkinson's who are eligible for DBS surgery and can manage delays in their daily medication routine. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand its benefits for more patients.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications, but it mentions that participants must be able to tolerate delays in taking their daily Parkinson's disease medications.
What is the safety track record for these treatments?
Studies have shown that deep brain stimulation (DBS) for Parkinson's disease is generally safe, though it carries some risks. One study reported serious side effects in about 55% of patients using DBS, compared to 44% of those taking only medication. These side effects can include infections or issues with the procedure's equipment.
Levodopa, a common drug for Parkinson's, also presents some side effects. Specifically, one study found that 89% of participants experienced side effects, though most were not severe. Levodopa is known to help control symptoms over the long term.
Both DBS and levodopa have been used for many years, demonstrating they are mostly safe but can cause some issues. Consulting a doctor is crucial to understand the risks and benefits for each individual situation.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because they offer a personalized approach to managing Parkinson's disease. Traditional treatments typically include medications like Levodopa and standard deep brain stimulation (DBS), which are not tailored to individual brain activity. However, these new methods use closed-loop DBS that either amplifies or suppresses specific brain wave patterns, known as beta oscillations, in real-time. This could lead to more precise symptom control and potentially improve quality of life for patients. Additionally, by comparing these new methods to being off stimulation and medication, and to using Levodopa alone, researchers hope to understand how these innovative approaches can be integrated with existing treatments for better outcomes.
What evidence suggests that this trial's treatments could be effective for Parkinson's disease?
Research has shown that deep brain stimulation (DBS), one of the treatments studied in this trial, can improve movement in people with Parkinson's disease. It significantly reduces shaking, stiffness, and movement problems, with benefits lasting up to five years. Patients using DBS often require less medication, leading to fewer side effects.
Another treatment option in this trial is levodopa medication. Studies have demonstrated that levodopa reduces "off" times, periods when the medication isn't effective. This results in more "on" times, allowing patients to move more easily. Both treatments are well-supported by evidence for enhancing the quality of life for those with Parkinson's disease.46789Are You a Good Fit for This Trial?
This trial is for people with Parkinson's Disease who are candidates for deep brain stimulation (DBS) surgery. Participants must be able to consent, tolerate delays in their regular medication, and not have conditions like secondary Parkinsonism or stroke.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
DBS Surgery and Initial Assessment
Participants undergo DBS implantation surgery and initial assessments are conducted
Treatment and Assessment
Participants receive closed-loop DBS and levodopa medication, with assessments conducted multiple times
Follow-up
Participants are monitored for changes in motor function and neural oscillations
What Are the Treatments Tested in This Trial?
Interventions
- Carbidopa/Levodopa
- Neurostimulation
Neurostimulation is already approved in United States, European Union for the following indications:
- Respiratory dysfunction in spinal cord injury patients
- Respiratory failure in spinal cord injury patients
- Neuropathic pain relief
Find a Clinic Near You
Who Is Running the Clinical Trial?
David Escobar
Lead Sponsor
The Cleveland Clinic
Collaborator