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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.