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

January 9, 2024 updated by: Universidad Francisco de Vitoria

Transcranial Direct Current Stimulation as Adjuvant to Gamified Rehabilitation for Upper Limb Function in Pediatric Non-progressive Brain Damage: a Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Paediatric brain damage is categorized into two main types: cerebral palsy, characterized by permanent impairments in posture and movement due to non-progressive brain injuries during gestation and early years of life, and acquired paediatric brain damage, which encompasses sudden brain injuries occurring after birth, stemming from various causes such as traumatic brain injuries, strokes, infections, and brain tumors. Cerebral palsy is estimated to affect 2 cases per 1,000 births, while acquired childhood brain damage exhibits variable incidences depending on the cause. Both categories manifest a broad spectrum of symptoms, ranging from motor and sensory impairments to cognitive, behavioral, and emotional issues, necessitating a transdisciplinary rehabilitation approach. Neuroplasticity has an essential role in function developing and recovery, because of that several rehabilitation techniques are based on this concept, such as virtual reality. Non-invasive brain stimulation is developed to enhance these neuroplasticity mechanisms and, used as a coadjuvant therapy, seeks to get greater and faster results from rehabilitation treatments. Specifically transcranial direct current stimulation (tDCS) has shown positive results in motor functions like gait, balance and upper limb function, when applied as anodal tDCS over M1 cortex. The aim of this study is to conduct an independent parallel randomized trial to assess the effectiveness of tDCS combined with virtual reality in paediatric brain damage in upper limb function, as well as study if the stimulation conducted in M1 cortex has influenced in another cerebral areas and therefore causes changes in cognitive functioning such as executive functions and attention.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan Pablo Romero Muñoz, PhD, MD
  • Phone Number: +34 91 409 09 03
  • Email: p.romero.prof@ufv.es

Study Contact Backup

  • Name: Marcos Ríos Lago, PhD
  • Phone Number: +34 91 409 09 03
  • Email: mrios@psi.uned.es

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Beata Maria Ana Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke.
  • Traumatic brain injury.
  • Cerebral palsy.
  • Acquired Brain Injury.
  • Other causes of non-progressive brain damage susceptible to treatment with the established procedures.
  • Evolution of the injury of at least one year.
  • Age between 7 and 15 years, with adequate language development and capacity to comprehend the proposed procedure.
  • Neuroimaging study done.
  • Absence of previous brain injuries prior to the one prompting treatment.
  • Score between II and IV on the MACS scale for manual ability assessment.
  • Signed informed consent by the patient and their legal guardian in case the participant is 12 or older. If the participant is younger than 12 years, only the caregiver signed informed consent will be necessary.
  • Increased tone according to the modified Ashworth scale ranging from 1 to 1+.
  • Minimum score of 1 on each item assessed in the Melbourne Assessment 2 scale.

Exclusion Criteria:

  • Dermatological problems in the electrode application area (psoriasis, dermatitis on the scalp or face).
  • Presence of implants or metal pieces in the head excluding fillings.
  • Pacemakers, medication pumps, stimulators (vagal, cerebral, transcutaneous), ventriculoperitoneal shunts, or aneurysm clips.
  • Neurological disease different from that described in the inclusion criteria.
  • Significant language difficulties that unable proper understanding of activities or severely limit expression.
  • Moderate or severe mood disorders diagnosed by the regular pediatrician.
  • Uncontrolled medical issues (acute phase pathologies without medical or pharmacological treatment with proven efficacy or life-threatening conditions).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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: 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.
Sham Comparator: Sham Transcranial Direct Current Stimulation

Sham Transcranial Direct Current (s-tDCS) will be applied over the Primary Motor Cortex during 10 sessions of 20 minutes.

The electrodes will be placed in the same positioned as for M1 stimulation in the experimental group, but the current will only be applied ramping for 30 seconds in the beginning and at the end of the procedure to secure 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 sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Melbourne Assessment 2 (MA-2)
Time Frame: From baseline at 2 weeks and 6 weeks
Upper limb functionality scale for children with neurological impairment from 2,5 to 15 years. It evaluates range of movement, target accuracy, fluency, grasp, accuracy of release, finger dexterity and speed. These elements are scored separately based on the execution of 16 different activities, giving a 0 to 4 or 0 to 3 punctuation in 36 different items.
From baseline at 2 weeks and 6 weeks
Changes in kinematic and kinetic upper limb analysis - Velocity of the movement
Time Frame: From Baseline at 2 weeks and 6 weeks

The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France).

The analysis will include mean and peak velocity of the movement, addressed in meters per second (m/s).
From Baseline at 2 weeks and 6 weeks
Changes in kinematic and kinetic upper limb analysis - Movement acceleration
Time Frame: From Baseline at 2 weeks and 6 weeks

The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France).

The analysis will include movement acceleration, addressed in meters per second squared (m/s^2).
From Baseline at 2 weeks and 6 weeks
Changes in kinematic and kinetic upper limb analysis - Duration of the movement
Time Frame: From Baseline at 2 weeks and 6 weeks
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The time parameters included in the analyses will be: going phase, adjusting phase, returning phase and total movement duration. All measures will be addressed in seconds (s).
From Baseline at 2 weeks and 6 weeks
Changes in kinematic and kinetic upper limb analysis - range of motion
Time Frame: From Baseline at 2 weeks and 6 weeks

The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France).

The analysis will include range of motion of flex-extension of shoulder, elbow and wrist; horizontal abduction of the shoulder, radial and cubital deviation of the wrist and abduction and adduction of the shoulder. The markers needed to register the movement will be place according to Wu et al. protocol in sternocostoclavicular joints and xiphoid process for the trunk, acromioclavicular joint for the shoulder, medial and lateral epicondyles for the elbow, radial and ulnar styloid processes for the wrist and heads of the second and fourth metacarpals for the hand.

These measures will be addressed in degrees.
From Baseline at 2 weeks and 6 weeks
Changes in Box and Block Test (BBT)
Time Frame: From baseline at 2 weeks and 6 weeks
This test assesses dexterity. It consists of placing the greater number of cubes from one place to another in 60 seconds.
From baseline at 2 weeks and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in and grip strength
Time Frame: From baseline at 2 weeks and 6 weeks
Hand grip strength will be evaluated with a dynamometer
From baseline at 2 weeks and 6 weeks
Changes in finger flexor muscles spasticity
Time Frame: From baseline at 2 weeks and 6 weeks
Finger flexor muscle groups spasticity will be evaluated by AMADEO device (Tyromotion, Graz). The device assesses spasticity in the flexor muscle groups of the fingers based on the modified Ashworth scale (MAS), taking 3 measurements at 3 different speeds.
From baseline at 2 weeks and 6 weeks
Changes in finger extensor muscles spasticity
Time Frame: From baseline at 2 weeks and 6 weeks
Finger extensor muscle groups spasticity will be evaluated by AMADEO device (Tyromotion, Graz). The device assesses spasticity in the extensor muscle groups of the fingers based on the modified Ashworth scale (MAS), taking 3 measurements at 3 different speeds.
From baseline at 2 weeks and 6 weeks
Changes in Children's hand-use experience questionnaire (CHEQ)
Time Frame: From baseline at 2 weeks and 6 weeks
Measures Upper limb use in daily living activities and its subjective experience using the affected hand in activities where usually two hands are needed. This questionnaire can be answered by the children or the caregivers. It has 3 categories: hand use, time needed to complete the action in comparison with their equals and personal experience while conducting the action. It includes 27 different activities.
From baseline at 2 weeks and 6 weeks
Changes in Wechsler Intelligence Scale for Children V (WISC-V)
Time Frame: From baseline at 2 weeks and 6 weeks
Clinical instrument to assess intelligence in children from 6 to 16 years and 11 months. It provides scores of primary intelligence indices that reflect intellectual functioning in different cognitive areas: verbal comprehension, visuospatial ability, fluid reasoning, working memory, and processing speed. It also provides an overall intelligence score.
From baseline at 2 weeks and 6 weeks
Changes in Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI)
Time Frame: From baseline at 2 weeks and 6 weeks
This tool is a visual perception test which consists of a sequence of geometric figures, in ascending grade of complexity, to evaluate the visuomotor integration in individuals from 3 years to 17 years and 11 months old.
From baseline at 2 weeks and 6 weeks
Changes in Neuropsychological battery for children NEPSY-II
Time Frame: From baseline at 2 weeks and 6 weeks
It is a tool for conducting specific cognitive assessment by domains, from 3 to 16 years old, as it includes tests that assess attention and executive functions, language, memory and learning, sensorimotor functioning, visuospatial processing, and social perception.
From baseline at 2 weeks and 6 weeks
Changes in Test of Everyday Attention for Children (TEA-Ch) Changes in Test for everyday attention for children (TEA-Ch)
Time Frame: From baseline at 2 weeks and 6 weeks
This test evaluates the different types of attention (selective, divided and sustained) in visual and auditive modality for children between 6 and 12 years. It is composed of 9 subtests.
From baseline at 2 weeks and 6 weeks
Changes in Verbal learning test for children Spain-Complutense (TAVECI)
Time Frame: From baseline at 2 weeks and 6 weeks
This test is designed for evaluating memory and learning system in children between 3 and 16 years of age.
From baseline at 2 weeks and 6 weeks
Changes in Behavior rating inventory for executive function 2 (BRIEF-2)
Time Frame: From baseline at 2 weeks and 6 weeks
This is the international reference tool for assessing executive functioning for children between 5 and 18 years. It is reported from the parents, caregivers and teachers by questionnaires.
From baseline at 2 weeks and 6 weeks
Changes in Evaluation System for children and adolescents (SENA)
Time Frame: From baseline at 2 weeks and 6 weeks
This tool assesses a wide spectrum of emotional and conduct problems for children from 3 years to 18 through information of their environment.
From baseline at 2 weeks and 6 weeks
Changes in Kidscreen-52 scale
Time Frame: From baseline at 2 weeks and 6 weeks
It is a quality of life questionnaire that is completed both by the children and by their parents or caregivers. It includes several domains about situations and functions of the daily living, answering the questions with a punctuation from 1 to 5. The final score is obtained by summing each value: higher values correlate with a good quality of life perception and lower punctuations correlate with a poor quality of life perception.
From baseline at 2 weeks and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Francisco de Vitoria

Collaborators

Universidad Nacional de Educación a Distancia
Hospital Beata María Ana

Investigators

  • Principal Investigator: Juan Pablo Romero Muñoz, PhD, MD, Universidad Francisco de Vitoria
  • Principal Investigator: Marcos Ríos Lago, PhD, Universidad Nacional de Educación a Distancia
  • Principal Investigator: Beatriz Gavilán Agustí, PhD, Hospital Beata María Ana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHILDBOOST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual anonymized participant data will be available to other researchers under request.

IPD Sharing Time Frame

A year at the end of the study.

IPD Sharing Access Criteria

Individual anonymized participant data will be available to other researchers under request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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