RecruitingPhase 4NCT06316232

DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease

Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study


Sponsor

IRCCS Istituto delle Scienze Neurologiche di Bologna

Enrollment

20 participants

Start Date

Oct 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus deep brain stimulation (STN-DBS). One therapeutic strategy suggested in literature for improving gait disturbances is to increase the dose of dopaminergic drugs according to the hypothesis of pseudo-ON-freezing. The pseudo-ON-FoG in patients treated with STN-DBS can easily occur as the result of a suboptimal stimulation or the consequence of a post-operative reduction of the dopaminergic therapy. Therefore, it is reasonable hypothesize both the increase of stimulation and levodopa as good therapeutic strategies to improve pseudo-ON-FoG. At present there are no evidence for suppose that one option is better than the other, even though two recent studies on gait analysis reported a positive additive effect of levodopa therapy on gait parameters in patients treated with STN-DBS. In this study, the investigators aim to objectively evaluating the improvement of FoG in PD patients treated with STN-DBS at different treatment conditions consisting of increased intensity of stimulation or higher dosage of levodopa.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether increasing the dose of levodopa (a Parkinson's medication) can improve freezing of gait — a sudden, temporary inability to move the feet when walking — in patients with Parkinson's disease who already have a deep brain stimulation (DBS) device implanted but still experience this freezing problem. **You may be eligible if...** - You have Parkinson's disease and have had deep brain stimulation (DBS) of the subthalamic nucleus (STN) - Your DBS already controls your typical Parkinson's motor symptoms well (tremor, rigidity, slowness) - You still experience freezing of gait even during periods when your medication is working (ON state), confirmed by a questionnaire score **You may NOT be eligible if...** - You cannot walk independently for 10 meters - Your DBS settings cannot be adjusted without causing side effects - You have previously had severe side effects from high levodopa doses or increased DBS intensity (such as psychosis, hallucinations, severe movement problems, or low blood pressure) - You have significant dementia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESTIM ON plus

increase of intensity of stimulation of 0.5 mA bilaterally

DRUGMED ON plus

administration of a 2x levodopa morning dose


Locations(1)

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Italy

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NCT06316232


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