Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD. The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.

Detailed Description
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PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment. Randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.

Official Title
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A Double Blind, Crossover Study to Evaluate Safety and Efficacy of an Adaptive Deep Brain Stimulation Closed-loop Method Compared With Conventional Deep Brain Stimulation in Patients With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: adaptive Deep Brain Stimulation
* Device: conventional Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic PD; DBS implant since at least 3 years and in need of battery replacement, defined by battery level <25%; Patients must be able to sign the informed consent document to participate in the clinical trial; Patients with a suboptimal response to DBS treatment. Exclusion Criteria: Patients with severe cognitive decline (MMSE <25); Patients with major psychiatric issues; Patients with any medical condition potentially interfering with DBS battery replacement surgery; Patients that cannot tolerate an interruption of DBS stimulation; Patients taking only one levodopa dose per day; Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure; Pregnant or breastfeeding women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adaptive DBS<br>adaptive Deep Brain Stimulation, by AlphaDBSvext. | Device: adaptive Deep Brain Stimulation<br>* The investigational medical device (AlphaDBSvext) is a portable, external, dual mode stimulator that can deliver adaptive DBS or conventional DBS for the treatment of PD. In the adaptive mode, the device records Local Field Potential activity from the implanted DBS electrode and simultaneously delivers stimulation through the same electrode based on the recorded signal.<br>|
| Active Comparator: conventional DBS<br>conventional Deep Brain Stimulation, by AlphaDBSvext. | Device: conventional Deep Brain Stimulation<br>* The same investigational medical device (AlphaDBSvext) is used to deliver conventional DBS for the treatment of PD. In the conventional mode it delivers constant stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Electrical Energy Delivered (TEED) to the patient | Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode. | One day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device related Adverse Events (safety and tolerability) | Number of device relate Adverse Events or abnormal vital signs. | One day. | 
| Unified Parkinson's Disease Rating Scale (UPDRS) part III | Evaluation of motor symptoms through (UPDRS) part III, motor examination. The total score is computed from scores obtained on 18 items (0 best condition-4 worst condition), some considering multiple body parts. | One day. | 
| Unified Dyskinesia Rating Scale (UDysRS) | Evaluation of dyskinesia through repeated clinical assessments (using UDysRS). | One day. |