Reduce freezing episodes during 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 during 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
Plain-Language Summary
The goal is to see whether increasing subthalamic nucleus deep brain stimulation or increasing levodopa better reduces freezing of gait that persists even when other Parkinson's motor symptoms are well controlled. One approach, called STIM ON plus, raises the electrical stimulation to the subthalamic nucleus to directly modulate the abnormal motor circuits, while the MED ON plus approach raises levodopa to boost brain dopamine; DBS changes circuit activity without adding medication, and levodopa can improve movement but may increase dyskinesias or hallucinations in some people. The trial is looking for adults 18 to 80 who already have STN-DBS with good control of tremor, rigidity and bradykinesia but who still have daily ON-state freezing by the New Freezing of Gait Questionnaire, and it excludes people who cannot walk 10 meters independently, who cannot safely increase stimulation or levodopa because of prior severe side effects, or who have dementia (MMSE ≤18).
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 see whether increasing subthalamic nucleus deep brain stimulation or increasing levodopa better reduces freezing of gait that persists even when other Parkinson's motor symptoms are well controlled. One approach, called STIM ON plus, raises the electrical stimulation to the subthalamic nucleus to directly modulate the abnormal motor circuits, while the MED ON plus approach raises levodopa to boost brain dopamine; DBS changes circuit activity without adding medication, and levodopa can improve movement but may increase dyskinesias or hallucinations in some people. The trial is looking for adults 18 to 80 who already have STN-DBS with good control of tremor, rigidity and bradykinesia but who still have daily ON-state freezing by the New Freezing of Gait Questionnaire, and it excludes people who cannot walk 10 meters independently, who cannot safely increase stimulation or levodopa because of prior severe side effects, or who have dementia (MMSE ≤18).
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 3 years and 3 months.