AlphaDBS System for Parkinson's (NCT04681534)
Adaptive brain stimulation reduces tremor
- 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
- Adaptive brain stimulation reduces tremor
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Newronika
- Study Type
- INTERVENTIONAL
- Enrollment
- 15 participants
- Conditions
- Parkinson Disease
- Interventions
- AlphaDBS System
Summary For Families
The trial is testing whether a personalized form of deep brain stimulation can be given safely and might work better than standard continuous stimulation for people with Parkinson's who have or are getting a brain stimulator. It uses the AlphaDBS implantable pulse generator to do adaptive stimulation, meaning the device records brain electrical signals called local field potentials and adjusts stimulation; participants first do two hospital days where they receive each mode once, and those who tolerate it can then try each mode at home for two weeks over a month. They are enrolling adults who either need a generator replacement for an existing deep brain stimulator implanted for at least three years, or adults approved to receive new bilateral deep brain stimulation who pass routine medical and cognitive screening and show benefit from levodopa.
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 trial is testing whether a personalized form of deep brain stimulation can be given safely and might work better than standard continuous stimulation for people with Parkinson's who have or are getting a brain stimulator. It uses the AlphaDBS implantable pulse generator to do adaptive stimulation, meaning the device records brain electrical signals called local field potentials and adjusts stimulation; participants first do two hospital days where they receive each mode once, and those who tolerate it can then try each mode at home for two weeks over a month. They are enrolling adults who either need a generator replacement for an existing deep brain stimulator implanted for at least three years, or adults approved to receive new bilateral deep brain stimulation who pass routine medical and cognitive screening and show benefit from levodopa.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 4 years and 8 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- How many visits does this trial involve?
- You will have 2 days of in-hospital experimental sessions, and if eligible you may continue with a 1-month at-home follow-up (two weeks in each stimulation mode).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.