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

Universidad Francisco de Vitoria

Status: Not yet enrolling

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

Treatments: Device: Sham Transcranial Direct Current Stimulation; Device: Active Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06214364

CHILDBOOST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 7 to 15 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

Active transcranial direct current stimulation

Active Comparator group

Description:

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.

Treatment:

Device: Active Transcranial Direct Current Stimulation

Sham Transcranial Direct Current Stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcranial Direct Current Stimulation