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

Not Applicable

• Conditions: Advanced Parkinson's Disease
• Interventions: Device: aDBS; Device: DBS

• Registration Number: NCT02154724
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Timeline

• Study Start: 2013-09
• Status Verified: 2014-05
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-30
• Last Update Submitted: 2014-05-30
• Study First Posted: 2014-06-03
• Last Update Posted: 2014-06-03
• Primary Completion: 2014-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
aDBS	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.
aDBS	DBS	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.

Primary Outcome Measures

Name	Time	Method
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	up to 1 year	Counting the number of patient with adverse events (adimensional unit)

Trial Locations

Locations (1)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy