Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT06316232

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

Led by IRCCS Istituto delle Scienze Neurologiche di Bologna · Updated on 2024-03-18

20

Participants Needed

1

Research Sites

168 weeks

Total Duration

On this page

Sponsors

I

IRCCS Istituto delle Scienze Neurologiche di Bologna

Lead Sponsor

A

A.O.U. Città della Salute e della Scienza

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Parkinson's disease treated with STN-DBS who have good control of motor fluctuations and main motor symptoms
  • History of freezing of gait in daily ON condition after optimal DBS programming, defined by a score of 1 on Question 1 and  2 on Question 2 of the New Freezing of Gait Questionnaire
Not Eligible

You will not qualify if you...

  • Inability to walk independently for 10 meters
  • Limited therapeutic window preventing increasing stimulation intensity by 0.5 mA due to side effects
  • Previous severe adverse effects from high levodopa dose or increased STN-DBS intensity like psychosis, hallucinations, painful dyskinesias, severe hypotension, or digestive symptoms
  • Dementia with Mini-Mental State Examination score  18

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Italy, 40139

Actively Recruiting

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Research Team

I

Ilaria Cani

CONTACT

G

Giulia Giannini

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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