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

NCT ID: NCT02154724

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-09-30

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.

Conditions

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Advanced Parkinson's Disease

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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aDBS

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.

Group Type OTHER

aDBS

Intervention Type DEVICE

The aDBS is applied for 2 hours for two days with two different modalities (aDBS and DBS) in random order.

DBS

Intervention Type DEVICE

The aDBS s applied for two hous in DBS modality.

Interventions

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aDBS

The aDBS is applied for 2 hours for two days with two different modalities (aDBS and DBS) in random order.

Intervention Type DEVICE

DBS

The aDBS s applied for two hous in DBS modality.

Intervention Type DEVICE

Other Intervention Names

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adaptive deep brain stimulation Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Deep Brain Stimulation Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alberto Priori, Prof.

Role: CONTACT

Other Identifiers

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ADBS-2013-IRCCSMaggioreH

Identifier Type: -

Identifier Source: org_study_id

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