25 Participants Needed

Personalized Real-Time Deep Brain Stimulation for Parkinson's Disease

DE
JN
Overseen ByJeffrey Negrey, MA
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: David Escobar
Must be taking: Levodopa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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.46789

Are 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

I am a candidate for a specific brain surgery to help with my condition.
I have been diagnosed with Parkinson's disease without a known cause.
I can manage if there's a delay in my Parkinson's medication.
See 1 more

Exclusion Criteria

I do not have Parkinson's but have other brain conditions like stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DBS Surgery and Initial Assessment

Participants undergo DBS implantation surgery and initial assessments are conducted

1 week
In-person visits for surgery and initial assessments

Treatment and Assessment

Participants receive closed-loop DBS and levodopa medication, with assessments conducted multiple times

9 days
Multiple in-person visits for assessments

Follow-up

Participants are monitored for changes in motor function and neural oscillations

3-12 months
1 visit (in-person) for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Carbidopa/Levodopa
  • Neurostimulation
Trial Overview The study tests how well a personalized real-time DBS system works alongside standard medications like Carbidopa/Levodopa. It aims to understand the role of certain brain oscillations in Parkinson's and develop technology that adjusts treatment based on individual neural activity.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: eiDBS suppressionExperimental Treatment1 Intervention
Group II: eiDBS amplificationExperimental Treatment1 Intervention
Group III: Levodopa medicationExperimental Treatment1 Intervention
Group IV: Off DBSActive Control1 Intervention

Neurostimulation is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Neurostimulation for:
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Approved in European Union as Neurostimulation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

David Escobar

Lead Sponsor

Trials
1
Recruited
30+

The Cleveland Clinic

Collaborator

Trials
1,072
Recruited
1,377,000+

Published Research Related to This Trial

Neuromodulatory techniques are increasingly used to treat various neurological disorders, including chronic pain, Parkinson's disease, tremor, dystonia, and epilepsy, by targeting different areas of the nervous system.
The chapter reviews both current and past literature on these techniques, highlighting the mechanisms of deep brain stimulation and electrical neuro-network modulation as key components in managing these conditions.
DBS and electrical neuro-network modulation to treat neurological disorders.Thompson, A., Morishita, T., Okun, MS.[2012]
Operative neuromodulation involves using implanted devices to alter nerve signal transmission, showing promise in treating various conditions like chronic pain, spasticity, and respiratory disorders, which can significantly improve patient quality of life.
Emerging technologies in functional neuroprosthetics, such as endoneural prostheses and closed-loop systems, are paving the way for advanced treatments that could restore function in patients with neurological disabilities.
An introduction to operative neuromodulation and functional neuroprosthetics, the new frontiers of clinical neuroscience and biotechnology.Sakas, DE., Panourias, IG., Simpson, BA., et al.[2019]
Peripheral nerve stimulation (PNS) is a less invasive and potentially more cost-effective alternative to spinal cord stimulation (SCS) for treating neurogenic pain, as it targets specific painful areas directly.
A case report demonstrated significant pain relief from median nerve stimulation after SCS failed, highlighting the effectiveness of PNS, which remains underutilized and not widely accepted for reimbursement despite its safety and efficiency.
Refractory neuropathic pain from a median nerve injury: spinal cord or peripheral nerve stimulation? A case report.Dewandre, Q., Dubuisson, A., Kaschten, B., et al.[2022]

Citations

Long-term results of carbidopa/levodopa enteral ...Carbidopa/levodopa enteral suspension (CLES) previously demonstrated reduction in total daily OFF from baseline by over 4 hours in advanced Parkinson's disease ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36652111/
Comparative Effectiveness of Carbidopa/Levodopa Enteral ...This study evaluated the effectiveness of carbidopa/levodopa enteral suspension (CLES) and deep brain stimulation (DBS) on reducing pill burden in APD patients.
Long-term, continuous, subcutaneous levodopa/carbidopa ...One-year data from the ongoing BeyoND study (NCT02726386) showed that the ND0612 regimen was safe and well tolerated and provided a sustained ≥2-h improvement ...
IPX203 vs Immediate-Release Carbidopa-Levodopa for ...The results of this study suggest that IPX203 vs immediate-release carbidopa-levodopa may be useful in patients with Parkinson disease and motor fluctuations.
Three-Year Data from the Open-Label BeyoND study (PL4. ...One year data showed that ND0612 was safe and well-tolerated and provided a sustained ≥2-hour improvement in daily 'Good' ON-time without troublesome dyskinesia ...
DUOGLOBE: One‐Year Outcomes in a Real‐World Study ...These 12‐month outcome data show sustained, long‐term improvements and support the real‐world effectiveness of LCIG in patients with advanced PD. Safety was ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38499015/
Safety and efficacy of continuous subcutaneous levodopa ...Hierarchical testing ended after the fourth secondary endpoint. Adverse events were reported by 287 (89%) of 322 participants during open-label ...
Long-term results of carbidopa/levodopa enteral ...Carbidopa/levodopa enteral suspension (CLES) previously demonstrated reduction in total daily OFF from baseline by over 4 hours in advanced Parkinson's ...
Parkinson's disease quality of life at 12 months comparing ...Levodopa-carbidopa intestinal gel reduces dyskinesia in Parkinson's disease in a randomized trial. Mov. Disord. 36, 2615–2623 (2021) ...
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