STIM ON plus for Parkinson's (NCT06316232)
Reduce freezing episodes while walking
- Trial ID
- NCT06316232
- Official Title
- Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study
- Goal
- Reduce freezing episodes while walking
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- IRCCS Istituto delle Scienze Neurologiche di Bologna
- Study Type
- INTERVENTIONAL
- Enrollment
- 20 participants
- Conditions
- Freezing of Gait, Parkinson Disease
- Interventions
- STIM ON plus, MED ON plus
Summary For Families
The goal is to find out whether raising the strength of deep brain stimulation of the subthalamic nucleus or giving a higher dose of levodopa better reduces freezing of gait, the sudden stops in walking that cause falls and loss of independence. Participants try both options in random order while the tests are done blind; they will be video recorded and wear three motion sensors on the feet and lower back during timed walking, turning, and dual-task walking to measure freezing and walking quality. The team will also use standard movement and thinking tests and questionnaires to compare benefits and side effects like involuntary movements or other problems. The study is looking for 18 to 80-year-olds with Parkinson's who already have deep brain stimulation on both sides of that brain target, still have freezing when usually "on" after optimal programming, can walk independently at least 10 meters, and do not have significant dementia or a history of severe reactions to higher stimulation or levodopa.
Locations
- IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying STIM ON plus. The goal is to find out whether raising the strength of deep brain stimulation of the subthalamic nucleus or giving a higher dose of levodopa better reduces freezing of gait, the sudden stops in walking that cause falls and loss of independence. Participants try both options in random order while the tests are done blind; they will be video recorded and wear three motion sensors on the feet and lower back during timed walking, turning, and dual-task walking to measure freezing and walking quality. The team will also use standard movement and thinking tests and questionnaires to compare benefits and side effects like involuntary movements or other problems. The study is looking for 18 to 80-year-olds with Parkinson's who already have deep brain stimulation on both sides of that brain target, still have freezing when usually "on" after optimal programming, can walk independently at least 10 meters, and do not have significant dementia or a history of severe reactions to higher stimulation or levodopa.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- 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 Phase 4 trial is estimated to last approximately 3 years and 3 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 two in-person morning sessions.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Walking & movement tests (non-invasive); Wearable / at-home monitoring (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.