Transcranial Direct Current Stimulation and Gamified Rehabilitation for Upper Limb Function in Pediatric Brain Damage

Summary

The goal of this clinical trial is to acknowledge the effects of transcranial direct current stimulation as an adjuvant with gaming rehabilitation for upper limb function rehabilitation in paediatric population with non-progressive brain damage. The main questions it aims to answer are:

* Does tDCS boost upper limb function rehabilitation results adding as an adjuvant in paediatric brain damage?
* What domains related with upper limb function are most influenced by tDCS stimulation?
* What clinical variables are the best to predict the efficacy of the combined treatment?
* If the selected intervention causes changes in cognitive domains, and, if it occurs, see their relationship with the proposed intervention and the motor outcomes.

As a general objective, this trial seeks the validation of a protocol of non-invasive brain stimulation with tDCS as a complementary therapy for peadiatric population with brain injuries.

Participants will be randomly allocated into two groups: experimental group will receive anodal tDCS plus upper limb rehabilitation gaming system rehabilitation and control group will receive sham tDCS plus rehabilitation gaming system for upper limb rehabilitation. Both groups will conducted a virtual reality program with upper limb exercises while been stimulated either with anodal tDCS or sham tDCS.

Researchers will compare experimental and control groups to see if there is a difference in upper limb function and cognitive functions.

Conditions

• Paediatric Brain Damage
• Cerebral Palsy
• Paediatric Stroke
• Paediatric Traumatic Brain Injury
• Paediatric Acquired Brain Injury

Interventions

DEVICE

Active Transcranial Direct Current Stimulation

Active Anodal Transcranial Direct Current Stimulation (a-tDCS) will be applied over the Primary Motor Cortex of the affected or most affected hemisphere during 10 20 minute-sessions at 2 miliamps. The tDCS stimulator device will be used by an experienced physical therapist by a saline-soak pair of surface electrodes. The anode electrode will be placed over C3 (EEG 10/20 system) and the cathode electrode over the contralateral supraorbital area (Fp2), in order to enhance the excitability of M1. While the tDCS stimulation is administered, virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the tDCS stimulation.

DEVICE

Sham Transcranial Direct Current Stimulation

The electrodes will be placed in the same position as for the Primary Motor Cortex stimulation, as in the experimental group. Current will be applied for 30 seconds in the beginning and at the end for securing the blinding. While the sham tDCS stimulation is administered virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the tDCS stimulation.

Sponsors & Collaborators

• Universidad Nacional de Educación a Distancia

  collaborator OTHER

• Hospital Beata María Ana

  collaborator OTHER

• Universidad Francisco de Vitoria

  lead OTHER

Principal Investigators

• Juan Pablo Romero Muñoz, PhD, MD · Universidad Francisco de Vitoria

• Marcos Ríos Lago, PhD · Universidad Nacional de Educación a Distancia

• Beatriz Gavilán Agustí, PhD · Hospital Beata María Ana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-30

Primary Completion

2025-06-30

Completion

2026-01-31

Countries

• Spain

Study Locations