Transcranial Direct Current Stimulation and Dual Tasks

NCT05871359 | Unknown

• 1 other identifier: Ccppdezza
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease

Keywords

Parkinson; Transcranial direct current stimulation; Dual task; Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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)

  At baseline, after 45 days (t1) and 84 days (t2)

• Mini-best test,

  At baseline (t0),after 45 days (t1) and 84 days (t2)

• Freezing Of Gait questionnaire (FOG)

  At baseline (t0),after 45 days (t1) and 84 days (t2)

• Montreal Cognitive Assessment (MoCA; Conti et al., 2015)

  At baseline (t0), after 45 days (t1) and 84 days (t2)

• Digit Span Forward e Backward (Monaco et al. 2013)

  At baseline (t0),after 45 days (t1) and 84 days (t2)

Study Arms (2)

tDCS group

ACTIVE COMPARATOR

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

SHAM COMPARATOR

Sham group: patients carry out activities in Dual Task associated with tDCS sham.

Device: Transcranial Direct Current Stimulation; Procedure: Dual task

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Sham group; tDCS group

Dual task PROCEDURE

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..)

Sham group; tDCS group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Casa di Cura Privata del Policlinico SpA: lead

Study Sites (1)

Dipartimento di scienze neuroriabilitative, Casa di Cura del Policlinico

Milan, MI, 20144, Italy

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Massimo Corbo

  Department of Neurological Science Casa di Cura del Policlinico

  STUDY DIRECTOR

Central Study Contacts

Paola Antoniotti

CONTACT

00393474955464; antoniottipaola@gmail.com

Laura Veronelli

CONTACT

l.veronelli@casadicuraigea.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD candidate

Model Details: 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).

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: May 23, 2023
• Study Start: October 21, 2022
• Primary Completion: September 12, 2025
• Study Completion: December 20, 2025
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)