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Procedure

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

Phase 4
Recruiting
Research Sponsored by David Escobar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Determined, as per standard of care, to be a candidate for deep brain stimulation (DBS) surgery targeting either the subthalamic nucleus or the internal segment of the globus pallidus
Clinical diagnosis of idiopathic Parkinson's disease
Must not have
Secondary Parkinsonism, stroke, or progressive central nervous system disease other than Parkinson's disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data will be collected in assessment blocks multiple times throughout enrollment. assessments will be performed for up to nine days, starting the day after the dbs surgery. assessments may also be performed in one visit 3-12 months after dbs surgery.
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial uses brain stimulation, medication, and modeling to better understand Parkinson's to develop treatments that adjust in real-time to patient-specific neural activity. #MedicalResearch

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include those associated with Levodopa such as nausea, dizziness, and movement issues; plus risks from DBS surgery like infection, headache, confusion or speech problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a candidate for a specific brain surgery to help with my condition.
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I have been diagnosed with Parkinson's disease without a known cause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have Parkinson's but have other brain conditions like stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data will be collected in assessment blocks multiple times throughout enrollment. assessments will be performed for up to nine days, starting the day after the dbs surgery. assessments may also be performed in one visit 3-12 months after dbs surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and data will be collected in assessment blocks multiple times throughout enrollment. assessments will be performed for up to nine days, starting the day after the dbs surgery. assessments may also be performed in one visit 3-12 months after dbs surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Correlation between levodopa-related changes in UPDRS-III rigidity subscore and the amplitude of stimulation-evoked beta oscillations.
Correlation between levodopa-related changes in finger tapping speed and the amplitude of stimulation-evoked beta oscillations
Correlation between levodopa-related changes in forearm speed and the amplitude of stimulation-evoked beta oscillations
+6 more
Secondary study objectives
Correlation between levodopa-related changes in UPDRS-III bradykinesia subscore and the amplitude of stimulation-evoked beta oscillations
Correlation between levodopa-related changes in finger tapping displacement and the amplitude of stimulation-evoked beta oscillations
Correlation between levodopa-related changes in forearm displacement and the amplitude of stimulation-evoked beta oscillations
+6 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: eiDBS suppressionExperimental Treatment1 Intervention
Closed-loop evoked interference DBS that suppresses beta oscillations.
Group II: eiDBS amplificationExperimental Treatment1 Intervention
Closed-loop evoked interference DBS that amplifies beta oscillations.
Group III: Levodopa medicationExperimental Treatment1 Intervention
On-medication, off-stimulation
Group IV: Off DBSActive Control1 Intervention
Off-stimulation and off-medication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neurostimulation
2022
N/A
~60

Find a Location

Who is running the clinical trial?

David EscobarLead Sponsor
The Cleveland ClinicOTHER
1,053 Previous Clinical Trials
1,371,144 Total Patients Enrolled
~20 spots leftby Jun 2028
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