Personalize stimulation to reduce tremor
- Trial ID
- NCT07485621
- Official Title
- Assessing the Relation Between Subcortical LFPs and DBS Parameter Selection in Parkinson's Disease - a Prospective Study
- Goal
- Personalize stimulation to reduce tremor
- Status
- RECRUITING
- Sponsor
- Loes Laurijssen
- Study Type
- OBSERVATIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson's Disease (PD)
Summary For Families
It aims to find out whether tiny electrical rhythms from deep brain areas, called local field potentials or LFPs, can help clinicians choose DBS settings that control tremor, slowness, and stiffness while reducing side effects. Researchers will record LFPs from the implanted DBS electrodes during routine programming and look for patterns, like elevated beta-band activity that links to rigidity and bradykinesia, that predict which contacts, voltages, or frequencies work best. Because LFPs change with levodopa and motor state, the hope is that these signals could help personalize stimulation to work alongside medications, while participants receive standard clinical programming. Adults 18 and older with idiopathic Parkinson disease who are approved for DBS to treat refractory motor symptoms and who understand Dutch or French are eligible; about 40 people will be enrolled.
Locations
- University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. It aims to find out whether tiny electrical rhythms from deep brain areas, called local field potentials or LFPs, can help clinicians choose DBS settings that control tremor, slowness, and stiffness while reducing side effects. Researchers will record LFPs from the implanted DBS electrodes during routine programming and look for patterns, like elevated beta-band activity that links to rigidity and bradykinesia, that predict which contacts, voltages, or frequencies work best. Because LFPs change with levodopa and motor state, the hope is that these signals could help personalize stimulation to work alongside medications, while participants receive standard clinical programming. Adults 18 and older with idiopathic Parkinson disease who are approved for DBS to treat refractory motor symptoms and who understand Dutch or French are eligible; about 40 people will be enrolled.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 3 years.
- 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.