Parkinson DiseaseTdcs&DTNCT05871359
Transcranial Direct Current Stimulation and Dual Tasks
A study testing Transcranial Direct Current Stimulation and Dual task in people with Parkinson Disease, run by Casa di Cura Privata del Policlinico SpA at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial Direct Current Stimulation and Dual task
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 21 Oct 2022to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease patient (Hoehn and Yahr I-III);
- Ability to walk with or without aid for 100 meters,
- Mini Mental State Examination> 21,
- Ability to express informed consent
Who cannot join
- Inability of the patient to understand or perform the task based on the evaluation and judgment of the referring neuropsychologist and the investigator, and / or to sign or initial the informed consent;
- History of other previous, disabling neurological diseases (e.g., Stroke cerebri, Alzheimer's Disease, Multiple Sclerosis and Disabling Peripheral Neuropathy) and / or ongoing psychiatric diseases (e.g., major depression);
- Presence of contraindications to stimulation according to the most recent guidelines;
- Brain metal implants- Pace-makers, brain stimulators, cochlear implants- Pregnancy status (for women);
- Patient denial of informed consent.
Trial locations and contacts
1 site in 1 country.
Laura Veronelli contact
Italy1 site, 1 recruiting
- Recruiting
Dipartimento di scienze neuroriabilitative, Casa di Cura del Policlinico
Milan, MI, 20144
Paola Antoniotti, 00393474955464, antoniottipaola@gmail.com
About this study
Official title: "Transcranial Direct Current Stimulation and Dual Tasks in Parkinson's Disease-tDCS&DT in PD"
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial Direct Current Stimulation, Dual task
- Keywords
- Parkinson, Transcranial direct current stimulation, Dual task, Biomarkers
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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.
Dual taskProcedure or surgery
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..)
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Active comparator | transcranial Direct Current Stimulation group (tDCS group) : patients carry out activities in Dual Task associated with tDCS real. Receives: Device: Transcranial Direct Current Stimulation; Procedure: Dual task |
| Sham group | Sham comparator | Sham group: patients carry out activities in Dual Task associated with tDCS sham. Receives: Device: Transcranial Direct Current Stimulation; Procedure: Dual task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At baseline (t0) after 45 days (t1) and 84 days (t2)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: At baseline (t0),after 45 days (t1) and 84 days (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start21 Oct 2022
- Primary completion12 Sep 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into 2 groups, using REDCap (Research Electronic Data Capture) software (Harris et al, 2009): 15 / group and will carry out activities in Dual Task (DT) associated with transcranial Direct Current Stimulation (tDCS) real (test group) or sham (control group).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Privata del Policlinico SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Antoniotti, Casa di Cura Privata del Policlinico SpA
- Investigators
- Massimo Corbo, Study director, Department of Neurological Science Casa di Cura del Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871359
- Sponsor's protocol ID
- Ccppdezza
- Acronym
- Tdcs&DT
- Status last verified
- May 2023
- First submitted
- 6 Feb 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antal A, Alekseichuk I, Bikson M, Brockmöller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Flöel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9): Appollonio I, Leone M, Isella V et al (2005) The frontal assessment battery (FAB): normative values in an Italian population sample. Neurol Sci 26:108-116. Barbarotto, R., Laiacona, M., Frosio, R. et al. A normative study on visual reaction times and two Stroop colour-word tests. Ital J Neuro Sci 19, 161-170 (1998). Beck, A.T., Steer, R.A., & Brown, G.K. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation. Bloem BR, Marinus J, Almeida Q, Dibble L, Nieuwboer A, Post B, Ruzicka E, Goetz C, Stebbins G, Martinez-Martin P, Schrag A, Movement Disorders Society Rating Scales C Measurement instruments to assess posture, gait, and balance in Parkinson's disease: Critique and recommendations. Mov Disord. 2016. Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, et al. Transcranial direct current stimulation in Parkinson's disease: neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015. Caffarra, P., Vezzadini, G., Dieci, F., Zonato, F., & Venneri, A. (2002). Una versione abbreviata del test di Stroop: Dati normativi nella popolazione Italiana. Nuova Rivista di Neurologia, 12(4), 111-115. Carlesimo, G. A., Buccione, I., Fadda, L., Graceffa, A., Mauri, M., Lorusso, S., Bevilacqua, G., & Caltagirone, C. (2002). Standardizzazione di due test di memoria per uso clinico: Breve Racconto e Figura di Rey. Nuova Rivista di Neurologia, 12(1), 1-13. Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Papantonio AM, Mundi C, Caltagirone C, Carlesimo GA. Standardization and normative data obtained in the Italian population for a new verbal fluency instrument, the phonemic/semantic alternate fluency test. Neurol Sci. 2014 Mar;35(3):365-72. doi: 10.1007/s10072-013-1520-8. Epub 2013 Aug 21. PMID: 23963806. Conti S, Bonazzi S, Laiacona M, Masina M, Coralli MV. Montreal Cognitive Assessment (MoCA)-Italian version: regression based norms and equivalent scores. Neurol Sci. 2015 Feb;36(2):209-14. doi: 10.1007/s10072-014-1921-3. Epub 2014 Aug 20. PMID: 25139107. Christopher G. Goetz,1 * Barbara C. Tilley,2 Stephanie R. Shaftman,2 Glenn T. Stebbins,1 Stanley Fahn,3 Pablo Martinez-Martin,4 Werner Poewe,5 Cristina Sampaio,6 Matthew B. Stern,7 Richard Dodel,8 Bruno Dubois,9 Robert Holloway,10 Joseph Jankovic,11 Jaime Kulisevsky,12 Anthony E. Lang,13 Andrew Lees,14 Sue Leurgans,1 Peter A. LeWitt,15 David Nyenhuis,16 C. Warren Olanow,17,18 Olivier Rascol,19 Anette Schrag,20 Jeanne A. Teresi,21 Jacobus J. van Hilten,22 and Nancy LaPelle,23 for the Movement Disorder Society UPDRS Revision Task Forc. Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Scale Presentation and Clinimetric Testing Results. MOVEMENT DISORDER,2008. Cho SS, Strafella AP. rTMS of the left dorsolateral prefrontal cortex modulates dopamine release in the ipsilateral anterior cingulate cortex and orbitofrontal cortex. PLoS One. 2009 Aug 21;4(8):e6725. doi: 10.1371/journal.pone.0006725. PMID: 19696930; PMCID: PMC2725302. Fregni F, Boggio PS, Santos MC, Lima M, Vieira AL, Rigonatti SP, et al. Noninvasive cortical stimulation with transcranial direct current stimulation in Parkinson's disease. Mov Disord. 2006;21(10):1693-702. Felipe Fregni, MD, PhD, Mirret M. El-Hagrassy, MD, Kevin Pacheco-Barrios, MD, MSc, Sandra Carvalho, PhD, Jorge Leite, PhD, Marcel Simis, MD, PhD, Jerome Brunelin, PhD, Ester Miyuki Nakamura-Palacios, MD, PhD, Paola Marangolo, PhD, Ganesan Venkatasubramanian, MD, PhD, Daniel San-Juan, MD, PhD, Wolnei Caumo, MD, PhD, Marom Bikson, PhD, André R. Brunoni, MD, PhD, and Neuromodulation Center Working Group. Evidence-based guidelines and secondary meta-analysis for the use of transcranial direct current stimulation (tDCS) in neurological and psychiatric disorders, 2021.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Transcranial Direct Current Stimulation and Dual Tasks in Parkinson's Disease-tDCS&DT in PD"
- ClinicalTrials.gov ID
- NCT05871359
- Acronym / sponsor ID
- Tdcs&DT / Ccppdezza
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Transcranial direct current stimulation, Dual task, Biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Casa di Cura Privata del Policlinico SpAUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 12 Sep 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into 2 groups, using REDCap (Research Electronic Data Capture) software (Harris et al, 2009): 15 / group and will carry out activities in Dual Task (DT) associated with transcranial Direct Current Stimulation (tDCS) real (test group) or sham (control group).
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Active comparator | Device: Transcranial Direct Current Stimulation, Procedure: Dual tasktranscranial Direct Current Stimulation group (tDCS group) : patients carry out activities in Dual Task associated with tDCS real. |
| Sham group | Sham comparator | Device: Transcranial Direct Current Stimulation, Procedure: Dual taskSham group: patients carry out activities in Dual Task associated with tDCS sham. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parkinson's disease patient (Hoehn and Yahr I-III);
- Ability to walk with or without aid for 100 meters,
- Mini Mental State Examination> 21,
- Ability to express informed consent
Key exclusion criteria (5 listed)
- Inability of the patient to understand or perform the task based on the evaluation and judgment of the referring neuropsychologist and the investigator, and / or to sign or initial the informed consent;
- History of other previous, disabling neurological diseases (e.g., Stroke cerebri, Alzheimer's Disease, Multiple Sclerosis and Disabling Peripheral Neuropathy) and / or ongoing psychiatric diseases (e.g., major depression);
- Presence of contraindications to stimulation according to the most recent guidelines;
- Brain metal implants- Pace-makers, brain stimulators, cochlear implants- Pregnancy status (for women);
- Patient denial of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationThe 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. | Device | Sham group, tDCS group |
| Dual taskThe 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..) | Procedure or surgery | Sham group, tDCS group |
Primary outcome
Change of duration (seconds) of 10 Meters Walking Test (single and dual task)
Time frame: At baseline (t0) after 45 days (t1) and after 84 days (t2)
Patient has to walk for ten meters with (dual task) or without(single task) a cognitive task
Change of duration (seconds) of Time Up and Go (single and dual task)
Time frame: At baseline (t0) after 45 days (t1) and 84 days (t2)
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.
9 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS; part III-motor part)
Time frame: At baseline, after 45 days (t1) and 84 days (t2)
Mini-best test,
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Freezing Of Gait questionnaire (FOG)
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Montreal Cognitive Assessment (MoCA; Conti et al., 2015)
Time frame: At baseline (t0), after 45 days (t1) and 84 days (t2)
Digit Span Forward e Backward (Monaco et al. 2013)
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Wisconsin Card Sorting Test (Laiacona et al., 2000)
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Trail Making Test (TMT; Giovagnoli et al., 1996)
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).
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)
Time frame: At baseline (t0),after 45 days (t1) and 84 days (t2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- BackgroundAntal A, Alekseichuk I, Bikson M, Brockmöller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Flöel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9): Appollonio I, Leone M, Isella V et al (2005) The frontal assessment battery (FAB): normative values in an Italian population sample. Neurol Sci 26:108-116. Barbarotto, R., Laiacona, M., Frosio, R. et al. A normative study on visual reaction times and two Stroop colour-word tests. Ital J Neuro Sci 19, 161-170 (1998). Beck, A.T., Steer, R.A., & Brown, G.K. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation. Bloem BR, Marinus J, Almeida Q, Dibble L, Nieuwboer A, Post B, Ruzicka E, Goetz C, Stebbins G, Martinez-Martin P, Schrag A, Movement Disorders Society Rating Scales C Measurement instruments to assess posture, gait, and balance in Parkinson's disease: Critique and recommendations. Mov Disord. 2016. Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, et al. Transcranial direct current stimulation in Parkinson's disease: neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015. Caffarra, P., Vezzadini, G., Dieci, F., Zonato, F., & Venneri, A. (2002). Una versione abbreviata del test di Stroop: Dati normativi nella popolazione Italiana. Nuova Rivista di Neurologia, 12(4), 111-115. Carlesimo, G. A., Buccione, I., Fadda, L., Graceffa, A., Mauri, M., Lorusso, S., Bevilacqua, G., & Caltagirone, C. (2002). Standardizzazione di due test di memoria per uso clinico: Breve Racconto e Figura di Rey. Nuova Rivista di Neurologia, 12(1), 1-13. Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Papantonio AM, Mundi C, Caltagirone C, Carlesimo GA. Standardization and normative data obtained in the Italian population for a new verbal fluency instrument, the phonemic/semantic alternate fluency test. Neurol Sci. 2014 Mar;35(3):365-72. doi: 10.1007/s10072-013-1520-8. Epub 2013 Aug 21. PMID: 23963806. Conti S, Bonazzi S, Laiacona M, Masina M, Coralli MV. Montreal Cognitive Assessment (MoCA)-Italian version: regression based norms and equivalent scores. Neurol Sci. 2015 Feb;36(2):209-14. doi: 10.1007/s10072-014-1921-3. Epub 2014 Aug 20. PMID: 25139107. Christopher G. Goetz,1 * Barbara C. Tilley,2 Stephanie R. Shaftman,2 Glenn T. Stebbins,1 Stanley Fahn,3 Pablo Martinez-Martin,4 Werner Poewe,5 Cristina Sampaio,6 Matthew B. Stern,7 Richard Dodel,8 Bruno Dubois,9 Robert Holloway,10 Joseph Jankovic,11 Jaime Kulisevsky,12 Anthony E. Lang,13 Andrew Lees,14 Sue Leurgans,1 Peter A. LeWitt,15 David Nyenhuis,16 C. Warren Olanow,17,18 Olivier Rascol,19 Anette Schrag,20 Jeanne A. Teresi,21 Jacobus J. van Hilten,22 and Nancy LaPelle,23 for the Movement Disorder Society UPDRS Revision Task Forc. Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Scale Presentation and Clinimetric Testing Results. MOVEMENT DISORDER,2008. Cho SS, Strafella AP. rTMS of the left dorsolateral prefrontal cortex modulates dopamine release in the ipsilateral anterior cingulate cortex and orbitofrontal cortex. PLoS One. 2009 Aug 21;4(8):e6725. doi: 10.1371/journal.pone.0006725. PMID: 19696930; PMCID: PMC2725302. Fregni F, Boggio PS, Santos MC, Lima M, Vieira AL, Rigonatti SP, et al. Noninvasive cortical stimulation with transcranial direct current stimulation in Parkinson's disease. Mov Disord. 2006;21(10):1693-702. Felipe Fregni, MD, PhD, Mirret M. El-Hagrassy, MD, Kevin Pacheco-Barrios, MD, MSc, Sandra Carvalho, PhD, Jorge Leite, PhD, Marcel Simis, MD, PhD, Jerome Brunelin, PhD, Ester Miyuki Nakamura-Palacios, MD, PhD, Paola Marangolo, PhD, Ganesan Venkatasubramanian, MD, PhD, Daniel San-Juan, MD, PhD, Wolnei Caumo, MD, PhD, Marom Bikson, PhD, André R. Brunoni, MD, PhD, and Neuromodulation Center Working Group. Evidence-based guidelines and secondary meta-analysis for the use of transcranial direct current stimulation (tDCS) in neurological and psychiatric disorders, 2021.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruiting
Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease
Parkinson Disease
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 1
Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients
Parkinson Disease, Parkinson's Disease
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Veronelli contact
Massimo Corbo study director
Department of Neurological Science Casa di Cura del Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation and Dual task in people with Parkinson Disease, run by Casa di Cura Privata del Policlinico SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Antoniotti (00393474955464, antoniottipaola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of duration (seconds) of 10 Meters Walking Test (single and dual task) (time frame: At baseline (t0) after 45 days (t1) and after 84 days (t2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.