Protocol study for a randomised, controlled, double-blind, clinical trial involving virtual reality and anodal transcranial direct current stimulation for the improvement of upper limb motor function in children with Down syndrome

Abstract

IntroductionDown syndrome results in neuromotor impairment that affects selective motor control, compromising the acquisition of motor skills and functional independence. The aim of the proposed study is to evaluate and compare the effects of multiple-monopolar anodal transcranial direct current stimulation and sham stimulation over the primary motor cortex during upper limb motor training involving virtual reality on motor control, muscle activity, cerebral activity and functional independence.Methods and analysisA randomised, controlled, double-blind, clinical trial is proposed. The calculation of the sample size will be defined based on the results of a pilot study involving the same methods. The participants will be randomly allocated to two groups. Evaluations will be conducted before and after the intervention as well as 1 month after the end of the intervention process. At each evaluation, three-dimensional analysis of upper limb movement muscle activity will be measured using electromyography, cerebral activity will be measured using an electroencephalogram system and intellectual capacity will be assessed using the Wechsler Intelligence Scale for Children. Virtual reality training will be performed three times a week (one 20 min session per day) for a total of 10 sessions. During the protocol, transcranial stimulation will be administered concomitantly to upper limb motor training. The results will be analysed statistically, with a p value≤0.05 considered indicative of statistical significance.Ethical aspects and publicityThe present study received approval from the Institutional Review Board of Universidade Nove de Julho (Sao Paulo,Brazil) under process number 1.540.113 and is registered with the Brazilian Registry of Clinical Trials (N° RBR3PHPXB). The participating institutions have presented a declaration of participation. The volunteers will be permitted to drop out of the study at any time with no negative repercussions. The results will be published and will contribute evidence regarding the use of this type of intervention on children.

Virtual Reality in the Neurosciences: Current Practice and Future Directions

“…VR's ability to provide haptic feedback through reach and grasp movements in a VR environment has gained interest in rehabilitating children with mild unilateral and dystonic cerebral palsy (146,147). Additionally, studies are now being designed to evaluate the combination of motor movement training through VR paired with anodal transcranial stimulation, a form of transcranial stimulation that favors cortical excitability and depolarization, in the rehabilitation of upper limb movement in children with Down syndrome (148). VR with anodal transcranial stimulation also shows promising results for improving gait in people with motor disorders such as cerebral palsy (149).…”

Brain stimulation: a therapeutic approach for the treatment of neurological disorders

“…A study with 22 Down syndrome children of ages between 6 and 12 years showed that the application of 10 sessions of anodal tDCS on the primary motor cortex during the upper limb motor training enhanced motor control for a reach movement 78 . Similarly, a case report found that anodal tDCS combined with upper limb motor training led to improvement in duration and velocity of movement 79 .…”

Effect of Transcranial Direct Current Stimulation Combined With Xbox-Kinect Game Experience on Upper Limb Movement in Down Syndrome: A Case Report

“…We first performed a search of the literature and found that studies using kinematic variables for the evaluation and tDCS during the training protocol opted for C3 as the stimulation site for modulating the excitability of the motor region. To further add to the enhancement, we made the decision to stimulate two points of the motor cortex using the 10-20 electroencephalogram system, as suggested by Lopes et al (2017a). Thus, the anodes were positioned over C3 and C4, and the cathode was positioned over the belly of the deltoid muscle (Lopes et al, 2017a).…”

“…To further add to the enhancement, we made the decision to stimulate two points of the motor cortex using the 10-20 electroencephalogram system, as suggested by Lopes et al (2017a). Thus, the anodes were positioned over C3 and C4, and the cathode was positioned over the belly of the deltoid muscle (Lopes et al, 2017a). We then noticed positive points, such as an increase in the stimulation of the motor region, as well as a negative point, namely, a larger field of stimulation increased the odds that the individual would perceive the stimulation.…”