protocolSection identificationModule nctId: NCT06316232, orgStudyIdInfo id: DBS-FOG 2023, briefTitle: DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: IRCCS Istituto delle Scienze Neurologiche di Bologna, class: OTHER, collaborators name: Azienda Ospedaliera Città della Salute e della Scienza di Torino, descriptionModule briefSummary: 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., conditionsModule conditions: Freezing of Gait, conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In addition to baseline gait assessment performed in a morning session on MED ON/STIM ON condition (after usual levodopa morning dose and usual parameters of stimulation), patients are evaluated in two following morning sessions under different treatment conditions:1. STIM ON plus: evaluation after the administration of levodopa morning dose and the increase of intensity of stimulation of 0.5 mA bilaterally,2. MED ON plus: evaluation after the administration of a 2x levodopa morning dose with usual parameters of stimulation., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The count and duration of FoG episodes during the standardize walking protocol is measured on video-assessment by two blind raters., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: STIM ON plus, interventions name: MED ON plus, outcomesModule primaryOutcomes measure: Time spent with FOG during protocol, secondaryOutcomes measure: Gait performance, secondaryOutcomes measure: MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III, secondaryOutcomes measure: Patient global impression of change (PGI-C), secondaryOutcomes measure: Trail Making test A and B, secondaryOutcomes measure: Phonemic/Semantic alternate Fluency test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto delle Scienze Neurologiche di Bologna, status: RECRUITING, city: Bologna, zip: 40139, country: Italy, contacts name: Ilaria Cani, role: CONTACT, phone: 0039 051 4966959, email: ilaria.cani@studio.unibo.it, contacts name: Giulia Giannini, role: CONTACT, phone: 0039 051 4966959, email: giulia.giannini15@unibo.it, contacts name: Giovanna Calandra Buonaura, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Ilaria Cani, MD, role: SUB_INVESTIGATOR, contacts name: Carlo Alberto Artusi, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Giulia Giannini, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False