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Device

Closed Loop DBS for Parkinson's Disease

N/A

Waitlist Available

Led By Dennis A Turner, M.D.

Research Sponsored by Dennis Turner, M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS

Has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations)

Must not have

Has severe neurological injury or disease other than Parkinson's Disease

Is not a safe surgical candidate for DBS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months after ipg implant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether two electrode placements are better than one for treating Parkinson's Disease. An adaptive system will also be developed.

Who is the study for?

This trial is for individuals with severe Parkinson's Disease who are candidates for deep brain stimulation (DBS) surgery. Participants must be able to consent, attend follow-ups, have levodopa-related side effects, and show at least a 30% improvement with levodopa. Excluded are those with dementia, pregnancy, unsafe surgical risks, other severe neurological diseases or conditions requiring MRIs, untreated depression, electromagnetic implants or metallic implants.

What is being tested?

The study tests the effectiveness of DBS electrodes implanted in two common brain areas (STN and GPi) versus just one area. It also aims to develop an adaptive DBS system that adjusts based on brain signal measurements from these electrodes.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, headache following surgery, infection risk from the procedure itself as well as possible speech or balance issues related to changes in brain stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Parkinson's Disease and am eligible for brain surgery.

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I experience side effects from levodopa, like sudden movements or fluctuations in my condition.

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My symptoms improve by at least 30% when I take levodopa.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe neurological condition, but it's not Parkinson's Disease.

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I am not considered safe for deep brain stimulation surgery.

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I have a history of seizures.

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I have had brain surgery to destroy brain tissue for medical reasons.

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I do not have dementia affecting my understanding or decision-making.

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I have depression that hasn't been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months after ipg implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months after ipg implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months after ipg implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 12 months after IPG implant.

Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 24 months after IPG implant.

Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 48 months after IPG implant.

+1 more

Secondary study objectives

Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 12 months after IPG implant.

Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 24 months after IPG implant.

Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 48 months after IPG implant.

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Implanted RC+SExperimental Treatment4 Interventions

Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.

0 / 9Eligibility criteria met