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

NCT ID: NCT06214364

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-01-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Active Transcranial Direct Current Stimulation

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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).

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Nacional de Educación a Distancia

OTHER

Sponsor Role: collaborator

Hospital Beata María Ana

OTHER

Sponsor Role: collaborator

Universidad Francisco de Vitoria

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Pablo Romero Muñoz, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Francisco de Vitoria

Marcos Ríos Lago, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional de Educación a Distancia

Beatriz Gavilán Agustí, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Beata María Ana

Locations

Beata Maria Ana Hospital

Madrid, , Spain

Countries

Spain

Central Contacts

Juan Pablo Romero Muñoz, PhD, MD

Role: CONTACT

p.romero.prof@ufv.es

+34 91 409 09 03

Marcos Ríos Lago, PhD

Role: CONTACT

mrios@psi.uned.es

+34 91 409 09 03

References

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.

Reference Type: BACKGROUND

PMID: 32662125 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28111406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34309829 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27778158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33326122 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27866120 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28632467 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34513765 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37352444 (View on PubMed)

Other Identifiers

CHILDBOOST

Identifier Type: -

Identifier Source: org_study_id