Reduce tremor slowness and stiffness
- Trial ID
- NCT04681534
- Official Title
- A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered Through AlphaDBS System in Patients With Parkinson's Disease
- Goal
- Reduce tremor slowness and stiffness
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Newronika
- Study Type
- INTERVENTIONAL
- Enrollment
- 15 participants
- Conditions
- Parkinson Disease
- Interventions
- AlphaDBS System
Plain-Language Summary
The goal is to see whether adaptive deep brain stimulation can improve control of motor symptoms like tremor, slowness, and stiffness, while reducing side effects and saving battery life compared with standard continuous DBS. AlphaDBS is an implantable system that records local field potentials from the subthalamic nucleus or GPi and automatically adjusts stimulation in real time based on beta-band brain signals linked to bradykinesia and rigidity, so it works alongside levodopa rather than replacing it. The trial enrolls two groups: people with bilateral STN DBS using a Medtronic IPG who need battery replacement within 12 months, and new DBS candidates age 18 or older with levodopa-responsive Parkinson's for at least 5 years, moderate-stage disease, good cognition and mood, specific approved lead types, and caregiver support.
Locations
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
- IRCCS Istituto Neurologico Carlo Besta, Milan, Italy
- Azienda Ospedale Universitario di Padova - Università di Padova, Padova, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- AOU Città della Salute e della Scienza di Torino, Turin, Italy
- Maastricht Medical Center, Maastricht, Netherlands
- Copernicus Podmiot Leczniczy, Gdansk, Poland
- Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw, Poland
Frequently Asked Questions
- What is this trial testing?
- This trial is studying AlphaDBS System. The goal is to see whether adaptive deep brain stimulation can improve control of motor symptoms like tremor, slowness, and stiffness, while reducing side effects and saving battery life compared with standard continuous DBS. AlphaDBS is an implantable system that records local field potentials from the subthalamic nucleus or GPi and automatically adjusts stimulation in real time based on beta-band brain signals linked to bradykinesia and rigidity, so it works alongside levodopa rather than replacing it. The trial enrolls two groups: people with bilateral STN DBS using a Medtronic IPG who need battery replacement within 12 months, and new DBS candidates age 18 or older with levodopa-responsive Parkinson's for at least 5 years, moderate-stage disease, good cognition and mood, specific approved lead types, and caregiver support.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 8 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 4 years and 8 months.