Clinical Study for Adaptive Deep Brain Stimulation (aDBS)Controlled by Intracerebral Activity in Parkinson's Disease

Study Overview
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Brief Summary
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Despite its therapeutic effectiveness in Parkinson's disease (PD) the current deep brain stimulation (DBS) strategy could achieve an even better clinical result by adapting to patient's condition. As intracerebral activity analyzed by recording local field potentials (LFPs) from DBS electrodes correlates to PD symptoms, a new stimulation approach would be an intelligent adaptive DBS system able to change stimulation settings automatically to the patient's needs using LFPs as control variable.

Detailed Description
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Despite their proven efficacy in treating Parkinson's disease (PD), deep brain stimulation (DBS) systems could be further optimized to maximize treatment benefits. In particular, because current DBS strategies based on fixed stimulation settings leave the typical parkinsonian motor fluctuations and rapid symptom variations partly uncontrolled, research has focused on developing a novel adaptive DBS (aDBS) system able to adapt moment-by-moment to the patient's clinical condition. aDBS consists of a simple closed-loop model designed to measure and analyze a control variable reflecting the patient's clinical condition to change stimulation settings and send them to an intelligent implanted stimulator. Intracerebral activity analyzed by recording local field potentials (LFPs) from electrodes implanted for DBS in the past 15 years has helped in clarifying basal ganglia pathophysiology and its relation to PD symptoms. Many LFP studies have revealed unknown functions of basal ganglia in PD patients during the execution of motor, cognitive, and behavioral task showing the existence of a code in LFP oscillations corresponding to the of patient's clinical condition. LFP-clinical correlations should provide the rationale for developing and implementing new aDBS devices able to adapt stimulation parameters moment-by-moment to the individual patient's needs using LFPs as a control variable for feedback.

Official Title
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Clinical Investigation for Adaptive Deep Brain Stimulation (aDBS)Closed-loop Device Controlled by Local Field Potentials in Parkinson's Disease.

Conditions
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Advanced Parkinson's Disease

Intervention / Treatment
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* Device: aDBS
* Device: DBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each patient affected by Parkinson's Disease and implanted with DBS electrodes, following the inclusion criteria of L.I.M.P.E., 2003

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: aDBS<br>The aDBS (adaptive Deep Brain Stimulation) device is applied both in aDBS and in DBS modality, for two hours in random order for two days. The aDBS can be programmed to deliver aDBS controlled by local fields potential or conventional DBS. | Device: aDBS<br>* The aDBS is applied for 2 hours for two days with two different modalities (aDBS and DBS) in random order.<br>* Other names: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico;Device: DBS<br>* The aDBS s applied for two hous in DBS modality.<br>* Other names: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of improvement in unified parkindon's disease rating scale (UPDRS score) of aDSB compare to cDBS |  | up to1 year | 
| Number of participants with adverse events | Counting the number of patient with adverse events (adimensional unit) | up to 1 year |