Clinical Investigation for Adaptive Deep Brain Stimulation (aDBS)Closed-loop Device Controlled by Local Field Potentials in Parkinson's Disease.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Percentage of improvement in unified parkindon's disease rating scale (UPDRS score) of aDSB compare to cDBS
Study Overview
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 Design
- Study Type
- Interventional
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percentage of improvement in unified parkindon's disease rating scale (UPDRS score) of aDSB compare to cDBS
Time Frame: up to1 year
Number of participants with adverse events
Time Frame: up to 1 year
Counting the number of patient with adverse events (adimensional unit)
Secondary Outcomes
No secondary outcomes reported