An interventional study of Transcranial Direct Current Stimulation and Dual task in Parkinson Disease, sponsored by Casa di Cura Privata del Policlinico SpA. Recruiting at 1 site in Italy. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-05-23.
Sponsored by Casa di Cura Privata del Policlinico SpA · Not applicable, Interventional, and Treatment
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Among 347 studies in Parkinson Disease with a site in Italy — 90 open to participants now, 108 under way, 4 of them phase 3. Parkinson Disease · Italy.
Among the 347 studies in Parkinson Disease with a site in Italy, this one is the 197th largest by planned enrollment of the 244 interventional ones that give a count, is one of 29 that started in 2022, is one of 146 with no phase, reaches primary completion later than 25 of the 107 other live ones, and was the 233rd registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →90 of the 347 studies in Parkinson Disease with a site in Italy are open now. Recruiting first, the newest first:
University Hospital Tuebingen · Sites in Italy, France, Germany and 4 more countries
Ages 35–80
Newronika · Sites in Italy
Ages 18+
University Hospital of Ferrara · Sites in Italy
Ages 18+
Universita di Verona · Sites in Italy
Ages 18+
Neuromed IRCCS · Sites in Italy
Ages 18+ · Healthy volunteers
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
347 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 37 · Phase 3 49 · Phase 4 13
First in 2002; this study’s year is marked. 29 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 82 across the 244 interventional studies, 145 across the 102 observational. Of the 184 that completed or were terminated, 50 (27%) have results posted.
This tab as a report to print or save as PDF → With an account.
109 of 347 have an industry lead sponsor. The 10 most frequent:
Casa di Cura Privata del Policlinico SpA is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Casa di Cura Privata del Policlinico SpA has 2 studies filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
22 of the studies in Parkinson Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07502066IRCCS San Camillo, Venezia, ItalyClinical Efficacy of a telerehabilItation Protocol, for the Improvement of Balance in Degenerative Neurological Diseases | 2026-12 |
| NCT07485218University of Applied Sciences and Arts of Southern SwitzerlandMultidimensional Assessment of Fatigability in Older Adults Living in Southern Switzerland and Elderly With Parkinson's Disease | 2026-12 |
| NCT07637123IRCCS San Raffaele RomaEvaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients | 2026-12 |
| NCT07616050Marta MondelliniEvaluation of the Impact of Virtual Park on Training Motivation in Adult Patients | 2026-12 |
| NCT06814431Azienda USL Reggio Emilia - IRCCSStudy on the Incidence of Malignant Neoplasms in Patients With Parkinson's Disease and Heterozygous Mutation of the GBA Gene | 2026-12 |
Add all 22 to your calendar (.ics) → With an account.
Among the 347 studies in Parkinson Disease with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The project aims to evaluate the clinical and biological effects on patients with Parkinson's disease of an innovative treatment characterized by the use of transcranial Direct Current Stmulation (tDCs) with Dual Task (DT), i.e. including the performance of motor activities in conjunction with the request of cognitive performance, such as executive functions (creative flexibility, working memory and divided attention).
Randomized controlled, double-blind, non-pharmacological study using device.The project involves the enrollment of 30 patients.Participants will be randomized into 2 groups: 15 / group and will carry out activities in DT associated with tDCS real (test group) or sham (control group). Each will carry out 12 rehabilitation sessions (2 / week) of 30 minutes. A follow-up is foreseen for all 12 weeks after the end of the treatment.
Patients will undergo, at baseline (T0), at the end of the session (T1) and at 12 weeks (T2), a motor and a cognitive profile, moreover a blood sample will be taken.
The project intends to improve the state of Parkinson's patients both thanks to the type of protocol that associates DT and tDCS, and thanks to the verification of the treatment through personalized biological analyzes. In detail, improvement in clinical performance, space-time variables in gait and cognitive tests are expected; the variability of synaptic and pathological markers will serve to verify the effect of the treatment.
Parkinson's disease (PD) is a neurodegenerative disease characterized by motor symptoms such as tremor at rest, rigidity, bradykinesia, postural instability and cognitive deficits A growing number of studies show that transcranial direct current electrical stimulation (tDCS), a low-cost, non-invasive brain stimulation method, could potentially become a clinical tool for rehabilitation of patients with Parkinson's disease.
Furthermore, some studies have shown that walking deficit in patients with Parkinson's disease is exacerbated by adding a dual cognitive or motor task. Daily activities require walking while simultaneously performing cognitive and / or motor tasks, such as talking to a friend or carrying a glass of water. This is why there are Dual Task (DT) training programs for patients with Parkinson's disease. A recent systematic review and meta-analysis demonstrated that treatment in DT can be an effective method of improving walking in terms of walking speed and cadence, balance and other motor symptoms in patients with Parkinson's disease.
Future investigations are needed to determine stimulation characteristics and optimal dosage when combined with training in DT.
The present study aims to investigate whether the application of tDCS at the dorso lateral prefrontal cortex(DLPFC) region level can add significant improvements to the motor and cognitive profile in patients with Parkinson's disease.
Randomized controlled, double-blind, non-pharmacological study using device. The data will be collected at the Department of Neurorehabilitation Sciences of the Polyclinic Nursing Home in Milan.
The project involves the enrollment of 30 patients. Each patient will take part in the study after an overall assessment of the general medical conditions, in relation to the suitability for participation in the study, by the neurologist of the unit department of Neuromotor Rehabilitation.
Randomized quadruple-blind study in parallel groups, in which the therapist who will carry out the treatment and the patient will not be aware of the assignment to the group (experimental vs control). Participants will be randomized into 2 groups, using Research Electronic Data Capture (RedCap) software:15 / group and will carry out activities in DT associated with tDCS real (test group) or sham (control group). Each will carry out 12 rehabilitation sessions (2 / week) of 30 minutes. A follow-up is foreseen for all 12 weeks after the end of the treatment.
Patients will undergo, at baseline (T0), at the end of the session (T1) and at 12 weeks (T2), a motor and a cognitive profile, moreover a blood sample will be taken.
The project intends to improve the state of Parkinson's patients both thanks to the type of protocol that associates DT and tDCS, and thanks to the verification of the treatment through personalized biological analyzes. In detail, improvement in clinical performance, space-time variables in gait and cognitive tests are expected; the variability of synaptic and pathological markers will serve to verify the effect of the treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
transcranial Direct Current Stimulation group (tDCS group) : patients carry out activities in Dual Task associated with tDCS real.
Device: Transcranial Direct Current Stimulation · Procedure: Dual task
Sham group: patients carry out activities in Dual Task associated with tDCS sham.
Device: Transcranial Direct Current Stimulation · Procedure: Dual task
The stimulator will be connected to two electrodes .The active electrode will be placed on the areas of the dorsal lateral pre-frontal cortex (DLPFC) contralateral to the more affected side.The other one on the supra orbital area.
The Dual Task consists of walking for 20 minutes along a hallway, simultaneously patient has to answer to a different ecological cognitive (attention, fluences, calculation) and motor tasks (hold a tray, turn head, ecc..)
Change of duration (seconds) of 10 Meters Walking Test (single and dual task)
Patient has to walk for ten meters with (dual task) or without(single task) a cognitive task
Time frame: At baseline (t0) after 45 days (t1) and after 84 days (t2)
Change of duration (seconds) of Time Up and Go (single and dual task)
Patient has to sit from a chair, walk for 3 meters, turn and walk back to sit on the chair, with (dual task) or without (single task) a cognitive task.
Time frame: At baseline (t0) after 45 days (t1) and 84 days (t2)
Unified Parkinson's Disease Rating Scale (UPDRS; part III-motor part)
Assessment on motor performance (balance, walking, manual dexterity) UPDRS, the minimum value is 0,the maximum is 132, higher scores mean worse outcome.
Time frame: At baseline, after 45 days (t1) and 84 days (t2)
Mini-best test,
Assessment of balance, the minimum value is 0,the maximum is 28, higher scores mean better outcome.
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Freezing Of Gait questionnaire (FOG)
Assessment of freezing of gait .The minimum value is 0,the maximum is 24, higher scores mean worse outcome.
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Montreal Cognitive Assessment (MoCA; Conti et al., 2015)
Index of global cognitive and executive functioning
Time frame: At baseline (t0), after 45 days (t1) and 84 days (t2)
Digit Span Forward e Backward (Monaco et al. 2013)
The assessment of short-term and verbal working memory
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Wisconsin Card Sorting Test (Laiacona et al., 2000)
To assess planning, flexibility and monitoring skills in a complex problem-solving task
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Trail Making Test (TMT; Giovagnoli et al., 1996)
Processing speed index and attentional shifting
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Italian version of the Parkinson's Disease-Cognitive Rating Scale (PD-CRS; Santangelo et al., 2014).
Tests for the assessment of immediate verbal memory, visual comparison naming, sustained attention, working memory, clock drawing, deferred verbal memory, alternating fluency, verbal fluency of actions
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Biomarkers (Brain Derived Neurotrophic Factor BDNF, dopamine, synaptic proteins, α-synuclein, inflammatory and oxidative stress factors, circRNA, miRNA, with techniques of biochemistry, genetics and immunohistochemistry)
A blood sample will be taken to acquire plasma, serum and exosomes.
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Plan to share: No
Started Oct 2022 (actual). Primary completion is estimated for Sep 2025, 34 months after the start.
Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 34 months is above that.
Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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Casa di Cura Privata del Policlinico SpA