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

NCT06214364 | Unknown

• 1 other identifier: CHILDBOOST
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tDCS; NIBS; Virtual reality; Upper limb function; Paediatric brain damage; Cerebral palsy; Paediatric stroke; Paediatric acquired brain injury

Outcome Measures

Primary Outcomes (6)

• Changes in Melbourne Assessment 2 (MA-2)

  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

  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

  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

  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

  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)

  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 Outcomes (12)

• Changes in and grip strength

  From baseline at 2 weeks and 6 weeks

• Changes in finger flexor muscles spasticity

  From baseline at 2 weeks and 6 weeks

• Changes in finger extensor muscles spasticity

  From baseline at 2 weeks and 6 weeks

• Changes in Children's hand-use experience questionnaire (CHEQ)

  From baseline at 2 weeks and 6 weeks

• Changes in Wechsler Intelligence Scale for Children V (WISC-V)

  From baseline at 2 weeks and 6 weeks

Study Arms (2)

Active transcranial direct current stimulation

ACTIVE COMPARATOR

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

Sham Transcranial Direct Current Stimulation

SHAM COMPARATOR

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

Interventions

Active Transcranial Direct Current Stimulation DEVICE

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.

Active transcranial direct current stimulation

Sham Transcranial Direct Current Stimulation DEVICE

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.

Sham Transcranial Direct Current Stimulation

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead
• Universidad Nacional de Educación a Distancia: collaborator
• Hospital Beata María Ana: collaborator

Study Sites (1)

Beata Maria Ana Hospital

Madrid, 28007, Spain

Location

Related Publications (9)

• Upadhyay J, Tiwari N, Ansari MN. Cerebral palsy: Aetiology, pathophysiology and therapeutic interventions. Clin Exp Pharmacol Physiol. 2020 Dec;47(12):1891-1901. doi: 10.1111/1440-1681.13379. Epub 2020 Aug 19.

  PMID: 32662125 BACKGROUND

• Araki T, Yokota H, Morita A. Pediatric Traumatic Brain Injury: Characteristic Features, Diagnosis, and Management. Neurol Med Chir (Tokyo). 2017 Feb 15;57(2):82-93. doi: 10.2176/nmc.ra.2016-0191. Epub 2017 Jan 20.

  PMID: 28111406 BACKGROUND

• Gmelig Meyling C, Verschuren O, Rentinck IR, Engelbert RHH, Gorter JW. Physical rehabilitation interventions in children with acquired brain injury: a scoping review. Dev Med Child Neurol. 2022 Jan;64(1):40-48. doi: 10.1111/dmcn.14997. Epub 2021 Jul 26.

  PMID: 34309829 BACKGROUND

• Khan F, Amatya B, Galea MP, Gonzenbach R, Kesselring J. Neurorehabilitation: applied neuroplasticity. J Neurol. 2017 Mar;264(3):603-615. doi: 10.1007/s00415-016-8307-9. Epub 2016 Oct 24.

  PMID: 27778158 BACKGROUND

• Choi JY, Yi SH, Ao L, Tang X, Xu X, Shim D, Yoo B, Park ES, Rha DW. Virtual reality rehabilitation in children with brain injury: a randomized controlled trial. Dev Med Child Neurol. 2021 Apr;63(4):480-487. doi: 10.1111/dmcn.14762. Epub 2020 Dec 16.

  PMID: 33326122 BACKGROUND

• Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.

  PMID: 27866120 BACKGROUND

• Moura RCF, Santos C, Collange Grecco L, Albertini G, Cimolin V, Galli M, Oliveira C. Effects of a single session of transcranial direct current stimulation on upper limb movements in children with cerebral palsy: A randomized, sham-controlled study. Dev Neurorehabil. 2017 Aug;20(6):368-375. doi: 10.1080/17518423.2017.1282050. Epub 2017 Feb 25.

  PMID: 28632467 BACKGROUND

• Ko EJ, Hong MJ, Choi EJ, Yuk JS, Yum MS, Sung IY. Effect of Anodal Transcranial Direct Current Stimulation Combined With Cognitive Training for Improving Cognition and Language Among Children With Cerebral Palsy With Cognitive Impairment: A Pilot, Randomized, Controlled, Double-Blind, and Clinical Trial. Front Pediatr. 2021 Aug 25;9:713792. doi: 10.3389/fped.2021.713792. eCollection 2021.

  PMID: 34513765 BACKGROUND

• Collange-Grecco LA, Cosmo C, Silva ALS, Rizzutti S, Oliveira CS, Muszkat M. Effects of Dual Task Training and Transcranial Direct Current Stimulation in Children with Spastic Cerebral Palsy: A Pilot Randomized Control Trial. Dev Neurorehabil. 2023 Jul;26(5):279-286. doi: 10.1080/17518423.2023.2228400. Epub 2023 Jun 23.

  PMID: 37352444 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Pablo Romero Muñoz, PhD, MD

CONTACT

+34 91 409 09 03; p.romero.prof@ufv.es

Marcos Ríos Lago, PhD

CONTACT

+34 91 409 09 03; mrios@psi.uned.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation concealment: allocation sequence will be generated by an independent investigator. Group code number will be placed in sealed envelopes, that will be opened by another investigator, ignoring which code corresponds with each intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is parallel randomized triple-blind controlled trial with two groups: experimental group will be administered active anodal tDCS and control group, with sham tDCS.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 19, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 9, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: A year at the end of the study.
• Access Criteria: Individual anonymized participant data will be available to other researchers under request

Locations

ES (1)