Actively Recruiting
Safety and Efficacy of Adaptive Deep Brain Stimulation
Led by Newronika · Updated on 2024-07-09
15
Participants Needed
8
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the "AlphaDBS" System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN) for DBS.
CONDITIONS
Official Title
Safety and Efficacy of Adaptive Deep Brain Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic Parkinson's Disease
- Bilateral DBS treatment in the subthalamic nucleus with specific Medtronic IPGs for at least 3 years needing battery replacement within 12 months
- Ability to understand and sign informed consent
- Age 18 years or older
- Diagnosed with levodopa-responsive idiopathic Parkinson's disease for 5 years or more
- Disease stage II, III, or IV on Hoehn and Yahr scale
- History of symptom improvement with levodopa
- Selected for bilateral STN or GPi DBS with specified leads
- DBS lead circuit integrity confirmed before IPG implantation
- MoCA score above 26 in best medical condition
- BDI-II score below 17 in best medical condition
- UPDRS-III improvement by at least 33% with levodopa challenge test
- Ability to understand study requirements and provide informed consent
- Responsible caregiver available to assist with diaries and compliance
- Stable Parkinson's medication for one month before surgery
- Willingness and ability to attend all study visits and follow procedures
You will not qualify if you...
- Severe cognitive decline with MoCA score less than 10
- Major psychiatric issues or conditions interfering with study conduct
- Medical conditions interfering with DBS battery replacement surgery
- Need to replace or reposition leads during IPG replacement
- More than 10 recurrent falls in 3 months prior to consent
- Inability to tolerate interruption of DBS for at least 30 minutes
- Taking less than one levodopa dose per day
- Unsuitable local field potential recordings or significant artifacts
- Pregnant or breastfeeding women
- Contraindications for DBS surgery including intracranial abnormalities or metallic implants
- History of suicide attempt or active suicidal thoughts
- Dementia, major depression, seizures, congestive heart failure, uncontrolled diabetes, dialysis, substance use disorders, or other severe medical conditions
- Conditions interfering with study procedures or data collection
- Terminal illness with survival less than 12 months
- Need for repeated MRI scans
- Requirement for diathermy, transcranial magnetic stimulation, or electroconvulsive therapy
- Presence of electrical or electromagnetic implants
- Use of implanted electrical stimulation devices or medication pumps
- Anticoagulant therapy that cannot be paused for more than 5 days before surgery
- History of cranial surgery for Parkinson's treatment
- Participation in another clinical study
- Female participants who are breastfeeding, pregnant, or not using adequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
2
IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Completed
3
Azienda Ospedale Universitario di Padova - Università di Padova
Padova, Italy
Withdrawn
4
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Completed
5
AOU Città della Salute e della Scienza di Torino
Turin, Italy
Completed
6
Maastricht Medical Center
Maastricht, Netherlands
Withdrawn
7
Copernicus Podmiot Leczniczy
Gdansk, Poland
Withdrawn
8
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Poland
Completed
Research Team
C
Costanza Conti, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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