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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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

David EscobarLead Sponsor

The Cleveland ClinicOTHER

1,030 Previous Clinical Trials

1,365,528 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criteria for this research limited to those aged 85 and under?

"This medical experiment only permits patients aged 40 to 80 years of age."

Answered by AI

How secure are the effects of eiDBS deterrence on individuals?

"Due to its Phase 4 status, our team has assigned eiDBS suppression a score of 3 for safety. This signifies that the therapy is approved and safe to use in clinical practice."

Answered by AI

May I partake in this medical experiment?

"To be eligible to participate in this clinical trial, applicants must have been diagnosed with Parkinson's and are between the ages of 40 and 80. Currently, 30 patients can join the study."

Answered by AI

Is there currently an enrollment period for this medical trial?

"Affirmative. According to clinicaltrials.gov, this experiment is actively seeking participants as of August 25th 2023 and was originally posted on September 15th2023. 30 patients are needed for the study which takes place at a single site."

Answered by AI

What is the total participant count of this clinical trial?

"Affirmative. According to information from clinicaltrials.gov, this medical trial initiated on September 15th 2023 and is currently recruiting new participants as of August 25th 2023. The study seeks 30 volunteers across 1 location."

Answered by AI

What goals are researchers hoping to achieve with this experiment?

"The primary objective of this trial is to evaluate the efficacy of eiDBS amplification versus off-stimulation on finger tapping speed. Secondary objectives include quantifying the effect of eiDBS suppression vs. off-stimulation on forearm displacement, as well as assessing the impact of eiDBS amplification over an extended period against a baseline measure for fist arm displacement using linear mixed-effects (LME) models. Data will be collected in assessment blocks multiple times throughout enrollment with assessments conducted up to 9 days after DBS surgery and one visit 3-12 months post procedure."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Real-Time DBS and PD Mechanisms

David Escobar 2023. "Personalized Real-Time DBS and PD Mechanisms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06013956.

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