NCT06316232 DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease
| NCT ID | NCT06316232 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | IRCCS Istituto delle Scienze Neurologiche di Bologna |
| Condition | Freezing of Gait |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-10-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2023-10-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Ilaria Cani
PRINCIPAL INVESTIGATOR
IRCCS Istituto delle Scienze Neurologiche di Bologna
Frequently Asked Questions
Who can join the NCT06316232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Freezing of Gait. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06316232 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06316232 currently recruiting?
Yes, NCT06316232 is actively recruiting participants. Contact the research team at ilaria.cani@studio.unibo.it for enrollment information.
Where is the NCT06316232 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06316232 clinical trial?
NCT06316232 is sponsored by IRCCS Istituto delle Scienze Neurologiche di Bologna. The principal investigator is Ilaria Cani at IRCCS Istituto delle Scienze Neurologiche di Bologna. The trial plans to enroll 20 participants.