Clinical trial NCT06214364: Transcranial Direct Current Stimulation and Gamified Rehabilitation for Upper Limb Function in Pediatric Brain Damage
Official title: Transcranial Direct Current Stimulation as Adjuvant to Gamified Rehabilitation for Upper Limb Function in Pediatric Non-progressive Brain Damage: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
Collaborators: name: Universidad Nacional de Educación a Distancia
name: Hospital Beata María Ana
First posted: 2024-01-19
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

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).

Primary outcomes:
measure: Changes in Melbourne Assessment 2 (MA-2)
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in kinematic and kinetic upper limb analysis - Velocity of the movement
timeFrame: From Baseline at 2 weeks and 6 weeks
measure: Changes in kinematic and kinetic upper limb analysis - Movement acceleration
timeFrame: From Baseline at 2 weeks and 6 weeks
measure: Changes in kinematic and kinetic upper limb analysis - Duration of the movement
timeFrame: From Baseline at 2 weeks and 6 weeks
measure: Changes in kinematic and kinetic upper limb analysis - range of motion
timeFrame: From Baseline at 2 weeks and 6 weeks
measure: Changes in Box and Block Test (BBT)
timeFrame: From baseline at 2 weeks and 6 weeks
Secondary outcomes:
measure: Changes in and grip strength
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in finger flexor muscles spasticity
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in finger extensor muscles spasticity
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in Children's hand-use experience questionnaire (CHEQ)
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in Wechsler Intelligence Scale for Children V (WISC-V)
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI)
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in Neuropsychological battery for children NEPSY-II
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in Test of Everyday Attention for Children (TEA-Ch) Changes in Test for everyday attention for children (TEA-Ch)
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in Verbal learning test for children Spain-Complutense (TAVECI)
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in Behavior rating inventory for executive function 2 (BRIEF-2)
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in Evaluation System for children and adolescents (SENA)
timeFrame: From baseline at 2 weeks and 6 weeks
measure: Changes in Kidscreen-52 scale
timeFrame: From baseline at 2 weeks and 6 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Beata Maria Ana Hospital
Study officials:
affiliation: Universidad Francisco de Vitoria
name: Juan Pablo Romero Muñoz, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Nacional de Educación a Distancia
name: Marcos Ríos Lago, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Beata María Ana
name: Beatriz Gavilán Agustí, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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