Comparing Stimulation and Levodopa for Freezing of Gait in Parkinson's
Compares higher brain stimulation and higher levodopa doses for freezing of gait in Parkinson's patients.
Key facts
- Who runs it
- IRCCS Istituto delle Scienze Neurologiche di Bologna
- Where
- Bologna, ItalySee the site
- Trial code
- Registry title
- DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 20 people, planned
- Started
- 10 Oct 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- STIM ON plus
- MED ON plus
- Record updated
- 18 March 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Parkinson's disease who have a deep brain stimulation device (STN-DBS) and still have episodes of freezing of gait while their medicine is working.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Parkinson's disease treated with STN-DBS, with good control of motor fluctuations and main motor symptoms (slowness, stiffness, tremor).
- Earlier treatment
- Must already be treated with subthalamic nucleus deep brain stimulation (STN-DBS) with optimal programming.
- Biomarker or test result
- History of freezing of gait in the daily-ON condition: score of 1 on Question 1 and score of 2 or more on Question 2 of the New Freezing of Gait Questionnaire.
Main reasons for not taking part
- Cannot walk 10 meters independently
- Stimulation cannot be raised by 0,5 mA because of side effects
- Earlier severe side effects with high levodopa dose or stronger STN-DBS, such as psychosis, hallucinations, painful dyskinesias, severe hypotension or digestive symptoms
- Dementia (MMSE score of 18 or less)
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Italy
- IRCCS Istituto delle Scienze Neurologiche di BolognaBologna, ItalyContact: Ilaria CaniTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- STIM ON plus/MED ON plusExisting treatment, for comparison
Patients were evaluated in two following morning sessions under different treatment conditions: 1. STIM ON plus (intervention 1) 2. MED ON plus (intervention 2)
Treatment: STIM ON plus and MED ON plus
- MED ON plus/STIM ON plusExisting treatment, for comparison
Patients were evaluated in two following morning sessions under different treatment conditions: 1. MED ON plus (intervention 2) 2. STIM ON plus (intervention 1)
Treatment: STIM ON plus and MED ON plus
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study
- Plain-language title
- Comparing Stimulation and Levodopa for Freezing of Gait in Parkinson'sGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06316232, who can take part
- Record updated
- 18 March 2024