Effect of Transcranial Direct Current Stimulation on Upper Extremity of Children With Hemiparesis
Condition: Cerebral Palsy Infantile
MeSH terms: Cerebral Palsy; Paresis
Study type: Interventional

Summary: 
      Purpose: The aim of the study is to determine the combined effect of transcranial direct
      current stimulation (tDCS) and activities in virtual reality on the functional recovery of
      the upper extremity function of the children with hemiparesis. Subjects: Forty children with
      infantile stroke with age group between (6-12 years) will be divided into two groups, the
      experimental group will receive tDCS plus VR while the control group will receive sham tDCS
      plus VR. All the children will receive tDCS for 30minutes with 1.5 mA intensity over the
      dominant motor cortex. Both groups will be treated for three times a week for 6 weeks.
      Instrumentation: The the Fugl-Meyer assessment, motricity index, and Modified Barthel index
      will be used to assess the dependent variables after the intervention.
    

Detailed description: 
      One in 4000 full-term infants develops arterial ischemic stroke at the time of birth.5 These
      children are commonly called an infantile stroke, infantile hemiplegia, perinatal stroke, and
      congenital hemiplegic cerebral palsy. Epileptic seizures are common in 24-45 % of children
      suffering from an infantile stroke within a month.6 Noninvasive brain stimulation (NIBS) is
      the novel method of delivering therapeutic currents to the brain for the purpose of diagnosis
      and treatment 7. There is an exponential increase in researches on the effect of NIBS on
      cognitive deficits. The NIBS has proven to cause neural modulation at the cortical level8.
      The effect of stimulation is either increased or decreased in neuronal activity, depending on
      the anodal and cathodal stimulation, firing rate, and period of the activation or
      inhibition910. There are two types of NIBS techniques safely practiced among humans, these
      are, Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation
      (tCDS)11. tCMS uses a weak magnetic field that transforms into beneficial currents into the
      brain for diagnostic (Single-pulse tCMS) or treatment purposes (repetitive tCMS). The
      inhibitory or excitatory cortical effects are achieved by decreasing or increasing the
      frequency and duration of tCMS 12. tCDS involves the use of weak direct or alternating
      current applied on the scalp via electrodes for the purpose of neural modulation13. The most
      popular form of tCDS device is a battery-operated stimulator capable of producing direct
      current ranging from 0.5-2.0 mA14. Neural modulation is achieved by altering the resting
      membrane potential. The anode causes increased excitability due to its depolarizing effect
      whereas the cathode electrode causes inhibition due to the hyperpolarization effect14.

      Virtual reality (KVR) is the use of a computer interface involving upper limb activity in
      pediatric rehabilitation. VR creates an artificial environment, presented to the user through
      appropriate sensory stimulations. Participants use the motion sensor mounted on the paretic
      hand to interact with the virtual environment. The participants will receive visual and
      auditory feedback. The purpose of the study is to evaluate the combined effect of virtual
      reality activities and tDCS on upper limb activity in children with hemiparesis.
    

Intervention name(s): Brain stimulator v3.0; Sham Comparator: Control group
Intervention type(s): Device; Other
Intervention description(s): Brain stimulator v3.0 will be used to deliver 1.5 mA current over the scalp corresponding to the primary motor cortex. The current will be delivered via two surface electrodes 5 × 5 cm placed on the scalp, validated by the previous research; The sham set-up will follow a similar protocol as the experimental group but the intensity of the current will be ceased after 30 seconds of stimulation. Participants in the Sham group will feel the identical sensation as the experimental group and will be unable to differentiate between actual and sham tDCS such procedure is validated in earlier studies
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: Transcranial direct stimulation + virtual related group: The group will receive the tCDS and VR Group 2: Sham Transcranial direct stimulation Group + virtual related group: The groups will only receive sham tCDS and VR.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment