StimSearch programming algorithm s… for Parkinson's (NCT06205043)
Improve motor function using StimSearch
- Trial ID
- NCT06205043
- Official Title
- Enhancing Deep Brain Stimulation Programming for Parkinson's Disease: A Semi- Automatic Algorithm-Guided Approach Using StimSearch- A Double Blind Randomized Study
- Goal
- Improve motor function using StimSearch
- Phase
- NA
- Status
- UNKNOWN
- Sponsor
- Jaslok Hospital and Research Centre
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease
- Interventions
- StimSearch programming algorithm software, Clinician based programming
Summary For Families
The goal is to make deep brain stimulation programming more efficient and effective, so people with Parkinson's get better symptom control sooner and with fewer visits. The approach uses StimSearch, a semi-automatic algorithm-guided software that analyzes patient assessments and proposes DBS parameter settings, and the study will compare those algorithm suggestions to usual clinician-based programming in a double-blind, randomized way. They are looking for people with confirmed bilateral idiopathic Parkinson's who have significant motor symptoms off medication (UPDRS III ≥ 25), who improved by at least 30% on a pre-operative levodopa challenge, who can give informed consent, and who do not have major psychiatric conditions like substantial depression.
Locations
- Jaslok Hospital And Research Centre, Mumbai, Maharashtra, India
Frequently Asked Questions
- What is this trial testing?
- This trial is studying StimSearch programming algorithm software. The goal is to make deep brain stimulation programming more efficient and effective, so people with Parkinson's get better symptom control sooner and with fewer visits. The approach uses StimSearch, a semi-automatic algorithm-guided software that analyzes patient assessments and proposes DBS parameter settings, and the study will compare those algorithm suggestions to usual clinician-based programming in a double-blind, randomized way. They are looking for people with confirmed bilateral idiopathic Parkinson's who have significant motor symptoms off medication (UPDRS III ≥ 25), who improved by at least 30% on a pre-operative levodopa challenge, who can give informed consent, and who do not have major psychiatric conditions like substantial depression.
- 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 1 location.
- 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 2 years and 1 month.
- 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.
- 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.