Clinical Study for Adaptive Deep Brain Stimulation (aDBS)Controlled by Intracerebral Activity in Parkinson's Disease (ADBS)
Primary Purpose
Advanced Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
aDBS
DBS
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Parkinson's Disease
Eligibility 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
Sites / Locations
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
aDBS
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of improvement in unified parkindon's disease rating scale (UPDRS score) of aDSB compare to cDBS
Number of participants with adverse events
Counting the number of patient with adverse events (adimensional unit)
Secondary Outcome Measures
Full Information
NCT ID
NCT02154724
First Posted
May 19, 2014
Last Updated
May 30, 2014
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT02154724
Brief Title
Clinical Study for Adaptive Deep Brain Stimulation (aDBS)Controlled by Intracerebral Activity in Parkinson's Disease
Acronym
ADBS
Official Title
Clinical Investigation for Adaptive Deep Brain Stimulation (aDBS)Closed-loop Device Controlled by Local Field Potentials in Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aDBS
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
aDBS
Other Intervention Name(s)
adaptive deep brain stimulation, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Intervention Description
The aDBS is applied for 2 hours for two days with two different modalities (aDBS and DBS) in random order.
Intervention Type
Device
Intervention Name(s)
DBS
Other Intervention Name(s)
Deep Brain Stimulation, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Intervention Description
The aDBS s applied for two hous in DBS modality.
Primary Outcome Measure Information:
Title
Percentage of improvement in unified parkindon's disease rating scale (UPDRS score) of aDSB compare to cDBS
Time Frame
up to1 year
Title
Number of participants with adverse events
Description
Counting the number of patient with adverse events (adimensional unit)
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Priori, Prof.
Email
alberto.priori@unimi.it
Facility Information:
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Clinical Study for Adaptive Deep Brain Stimulation (aDBS)Controlled by Intracerebral Activity in Parkinson's Disease
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