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

Advanced Parkinson's Disease Clinical Trial

— ADBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02154724
• Other study ID #: ADBS-2013-IRCCSMaggioreH
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2014
• Last updated: May 30, 2014
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: May 2014
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Alberto Priori, Prof.
• Email: alberto.priori[@]unimi.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Parkinson's Disease
• Parkinson Disease

Intervention

Device:
• aDBS
The aDBS is applied for 2 hours for two days with two different modalities (aDBS and DBS) in random order.
• DBS
The aDBS s applied for two hous in DBS modality.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of improvement in unified parkindon's disease rating scale (UPDRS score) of aDSB compare to cDBS		up to1 year	Yes
Primary	Number of participants with adverse events	Counting the number of patient with adverse events (adimensional unit)	up to 1 year	Yes