Virtual Reality Therapy and Transcranial Direct Current Stimulation in Cerebral Palsy.

NCT04044677 | Completed

• 1 other identifier: 99577318.0.0000.5390
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blinded randomized controlled crossover trial will be conducted, and all participants will undertake non-immersive VR tasks and tDCS-active or tDCS-sham. Group 1 will start with ten sessions of tDSC-active combined to VR tasks. After one-month washout, this group will be reallocated to another 10 sessions with tDCS-sham combined to VR tasks. In contrast, Group 2 will do the opposite protocol (participants will start allocated to ten sessions of TDCS-sham and VR tasks, and after one-month washout period will be reallocated to ten sessions of tDCS-active and VR tasks). All protocol will have the assessment of Autonomic Nervous System, through Heart Rate Variability Analysis.

Conditions

Cerebral Palsy

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)

tDSC-active

EXPERIMENTAL

The TDCS-active will be performed over ten consecutive sessions per weekday (i.e. one session daily, no stimulation during the weekend) during the practice of VR games, TDCS-active will be performed with a current of 1 mA and 20 min of duration (20 seconds of ramp-up and ramp-down). The stimulation target will be the M1 area, choosing the more functional side of the participant (C3 or C4). This group will perform the tDCS-sham after one-month washout.

Device: tDSC-active

tDCS-sham

SHAM COMPARATOR

The TDCS-sham will be performed over ten consecutive sessions per weekday (i.e. one session daily, no stimulation during the weekend). However, the electrodes will be positioned at the same sites of the tDCS-active and the device will be switched on for 20 seconds (with ramp-up and ramp-down), giving the children the initial sensation of the 1 mA current, but with no stimulation administered during the rest of the time. This sham protocol is already programmed in the device prior to data collection. This group will perform the tDCS-active after one-month washout.

Device: tDCS-sham

Interventions

tDSC-active DEVICE

10 sessions of active Transcranial Direct Current Stimulation combined to Virtual Reality therapy followed by a one-month washout and 10 sessions of sham Transcranial Direct Current Stimulation

tDSC-active

tDCS-sham DEVICE

10 sessions of sham Transcranial Direct Current Stimulation combined to Virtual Reality therapy followed by a one-month washout and 10 sessions of active Transcranial Direct Current Stimulation

tDCS-sham

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Agreement to participate in the research from their selves and their legal guardians (by signing assent form and consent form);
• Have a clinical diagnosis of CP done by a neuropediatric clinician with non- progressive etiology;
• GMFCS levels I to IV;
• MACS I and IV.

You may not qualify if:

• Lack of understanding of the the tasks. The understanding of the task will be evaluated through five attempts of each task in VR, because even with low IQ a large part of the adolescents can understand virtual tasks and interact with improvement of performance;
• Motor difficulties that impede the completing of the virtual tasks;
• Cardiac diseases (because of the HRV assessment).

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

Related Publications (1)

• da Silva TD, Fontes AMGG, de Oliveira-Furlan BS, Roque TT, Lima AII, de Souza BMM, Alberissi CAO, Silveira AC, de Moraes IAP, Collett J, Silva RP, Airoldi MJ, Ribeiro-Papa DC, Dawes H, Monteiro CBM. Effect of Combined Therapy of Virtual Reality and Transcranial Direct Current Stimulation in Children and Adolescents With Cerebral Palsy: A Study Protocol for a Triple-Blinded Randomized Controlled Crossover Trial. Front Neurol. 2020 Sep 2;11:953. doi: 10.3389/fneur.2020.00953. eCollection 2020.

  PMID: 32982950 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Talita D Silva, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The device DS-Stimulator, Neuroconn Mobile tDCS allows the blindness of the researcher and the participant, so the participants, researchers, and outcome assessors will remain blind to group allocation during the study. To ensure proper blinding, participants will receive codes and will be concealed from the allocation process by one different researcher. The researchers responsible for applying the intervention and the outcome assessors will not know the study design, allocation, objectives, and expected outcomes. In addition, for the blinding of the experimenter (responsible for applying the intervention), one assessor (responsible for randomization) will be in charge of giving the active device to the experimenter.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group 1 will start with ten sessions of tDSC-active combined to VR tasks. After one-month washout, this group will be reallocated to another 10 sessions with tDCS-sham combined to VR tasks. In contrast, Group 2 will do the opposite protocol (participants will start allocated to ten sessions of TDCS-sham and VR tasks, and after one-month washout period will be reallocated to ten sessions of tDCS-active and VR tasks).

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: January 20, 2019
• Primary Completion: July 20, 2019
• Study Completion: August 1, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Probably from November 1st, forever.
• Access Criteria: By accessing the papers published by our group.

Locations

BR (1)