Transcranial Direct Current Stimulation (tDCS) and Virtual Reality Task in Parkinson Disease

NCT04527809 | Unknown

• 1 other identifier: 02908218.0.0000.5390
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blinded randomized controlled trial will be conducted, and all the participants will undertake one session of non-immersive VR tasks and tDCS-active or tDCS-sham. It will be a cross-sectional protocol. All protocol will have the assessment of Autonomic Nervous System, through Heart Rate Variability Analysis.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Motor skills improvement

  The motor skills will be analyzed through the games developed specifically for analysis of motor skills, such as (interception skills, speed, accuracy and reaction time).

  8 weeks.

Secondary Outcomes (1)

• Heart Rate Variability

  8 weeks.

Study Arms (2)

tDCS-active

EXPERIMENTAL

tDCS-active will be performed over one session during the practice of VR games. The frequency of current applied will be 2mA. The stimulation intensity will be set at 100%, and the anodal electrode will be at the M1 area, and the cathodal electrode at the contralateral supraorbital area.

Device: tDCS-active

tDCS-sham

SHAM COMPARATOR

tDCS-sham will be performed over one session during the practice of VR games. The frequency of current applied will be 2mA. The stimulation intensity will be set at 100%, and the anodal electrode will be at the M1 area, and the cathodal electrode at the contralateral supraorbital area. For the TDCS-sham the same active procedure setting will be used, however, the current will be interrupted after 20 seconds. This configuration will ensure that the electrical stimulus is interrupted before generating considerable stimuli, while the other characteristics of the intervention will be maintained.

Device: tDCS-sham

Interventions

tDCS-active DEVICE

One session of active Trasncranial Direct Current Stimulation combine to a Virtual Reality task.

tDCS-active

tDCS-sham DEVICE

One session of sham Trasncranial Direct Current Stimulation combine to a Virtual Reality task.

tDCS-sham

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's Disease with diagnosis previoulsy confirmed by a specialized doctor.
• Agreement to participate in the research by signing the informed consent form.

You may not qualify if:

• Wheelchair use
• Unable to complete the procedures due to any reported fatigue.
• Unable to complete the procedures due having to leave previously.
• Could not stand without any kind of help, such as a carrier or walking aids.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Arts, Sciences and Humanities of the University of Sao Paulo

São Paulo, São Paulo, 03828000, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Talita D Silva, Ph.D.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants, researchers and outcome assessors will remain blind throughout the study. To ensure proper blinding, the researcher responsible for that, will configurate the code of the tDCS device to sham or active before the proper application. It will be no difference between the devices for sham or active application of the tDCS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: The participants will undertake a single session of non-immersive VR tasks and tDCS-active or tDCS-sham.

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 27, 2020
• Study Start: July 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)