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Transcranial Direct Current Stimulation and Dual Tasks

NCT05871359 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-23

No results posted yet for this study

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

Interventions

DEVICE

Transcranial Direct Current Stimulation

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.

PROCEDURE

Dual task

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..)

Sponsors & Collaborators

  • Casa di Cura Privata del Policlinico SpA

    lead OTHER

Principal Investigators

  • Massimo Corbo · Department of Neurological Science Casa di Cura del Policlinico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-21
Primary Completion
2025-09-12
Completion
2025-12-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05871359 on ClinicalTrials.gov