Using deep brain stimulation and levodopa to improve walking in Parkinson's patients
Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study
PHASE4 · IRCCS Istituto delle Scienze Neurologiche di Bologna · NCT06316232
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS Istituto delle Scienze Neurologiche di Bologna (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06316232 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are Parkinson's disease patients treated with subthalamic nucleus deep brain stimulation who experience freezing of gait despite optimal treatment.
Not a fit: Patients who cannot walk independently or have severe adverse reactions to increased stimulation or levodopa will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Freezing of Gait, Parkinson Disease, freezing of gait, gait disturbances, parkinson disease