Using deep brain stimulation and levodopa to improve walking in Parkinson's patients
Official title: Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study
Run by IRCCS Istituto delle Scienze Neurologiche di Bologna · NCT06316232 · Data updated 2026-11-12
This study is testing whether increasing deep brain stimulation or giving a higher dose of levodopa helps people with Parkinson's disease walk better and reduces freezing episodes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | IRCCS Istituto delle Scienze Neurologiche di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | October 10, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 18, 2024 |
| Trial ID | NCT06316232 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Parkinson's disease patients treated with subthalamic nucleus deep brain stimulation who experience freezing of gait despite optimal treatment.
✕Probably not a fit
Patients who cannot walk independently or have severe adverse reactions to increased stimulation or levodopa will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of increasing deep brain stimulation intensity versus administering a higher dose of levodopa in patients with Parkinson's disease who experience freezing of gait. It employs a cross-over, blind, randomized design, where patients will be videorecorded while performing various walking tasks to assess their gait and freezing episodes. The study will also collect demographic and clinical data to analyze the impact of these interventions on motor and cognitive functions. The primary goal is to determine which approach better alleviates freezing of gait symptoms.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and quality of life for Parkinson's patients suffering from freezing of gait.
How similar studies have gone: While there have been studies on gait disturbances in Parkinson's disease, this specific approach of comparing stimulation intensity and levodopa dosage is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Parkinson's disease treated with STN-DBS who achieved a good control of motor fluctuations and cardinal motor symptoms (bradykinesia, rigidity, tremor) * History of FoG in daily-ON condition after optimal DBS programming, defined by a score of 1 on Question 1 and score ≥ 2 on Question 2 of the New Freezing of Gait Questionnaire. Exclusion Criteria: * inability to walk independently for 10 meters. * limited therapeutic windows of stimulation without the possibility of increase the intensity of stimulation of 0,5 mA for the appearance of side effects * previous evidence of severe adverse effects with high levodopa dose ore increased STN-DBS intensity, such as psychosis, hallucinations, painful dyskinesias, severe hypotension, digestive symptoms. * dementia (MMSE score ≤ 18)
Where it's running
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IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Ilaria Cani — IRCCS Istituto delle Scienze Neurologiche di Bologna
- Study coordinator: Ilaria Cani
- Email: ilaria.cani@studio.unibo.it
- Phone: 0039 051 4966959
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Decoding brain signals and DBS settings for freezing of gait in Parkinson’s
This study tests how brain activity and different DBS settings affect freezing of gait and balance in people with Parkinson’s who already have a Medtronic Percept DBS device.
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Remote mental practice to help with freezing of gait in Parkinson's disease
This study is testing if a combination of mental exercises and physical practice can help people with Parkinson's disease who struggle with freezing while walking.
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Percept recordings of brain activity during freezing of gait in Parkinson's disease
This research will use the Medtronic Percept DBS device to test whether brain electrical patterns differ during walking, movement transitions, and freezing in people with Parkinson's disease who do and do not experience freezing of gait.
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Thoracic epidural spinal cord stimulation to reduce freezing of gait in advanced Parkinson's disease
This study will try temporary thoracic spinal cord stimulation to see if it helps people with advanced Parkinson's disease whose freezing of gait does not respond to medications.
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CereGate Therapy for Freezing of Gait in Parkinson's Disease
This study is testing if CereGate therapy can help people with Parkinson's Disease who have freezing of gait feel more mobile and improve their movement after having deep brain stimulation.
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One-day exercise test to see how brain and body react in epilepsy, cognitive disorders, Parkinson's, dementia, and related conditions
A one-day study tests how an acute bout of exercise changes brain function and bodily signals in people with certain neurological conditions compared with healthy individuals.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.