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
- RECRUITING
- 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?
- 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 2 years and 1 month.
- 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.