Clinical trial NCT04257981: Effect of Transcranial Direct Current Stimulation on Upper Extremity of Children With Hemiparesis
Official title: Effect of Transcranial Direct Current Stimulation Augmented With Activities in Virtual Reality on Functional Recovery of the Upper Extremity of Children With Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy Infantile
Lead sponsor: Majmaah University
Sponsor class: OTHER
Collaborators: name: Shiekh Abdullah Al-Twejeri Research Chair for Stroke
First posted: 2020-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. The congenital stroke survivors with mild to moderate degree of upper limb disability on the Brunnstrom recovery scale16. The scores from 3-4 are considered moderate and 5-6 as a mild degree of upper-limb disability.
2. Age 5-12 years.
3. Able to understand simple commands.
4. Normal vision or with corrected glass

Exclusion Criteria:

1. Hemorrhage in the subarachnoid space
2. Aphasia
3. Neurosurgery of brain
4. Seizures in the past 12 months.
5. On medication for seizures.

Primary outcomes:
measure: Baseline and post- intervention Fugl-Meyer motor assessment
timeFrame: 8 Months
Secondary outcomes:
measure: Beiseline and post- intervention Motricity Index
timeFrame: 8 Months
measure: Baseline and post- intervention Modified Barthel Index
timeFrame: 8 Months
Other outcomes:
Locations:
city: Riyad
country: Saudi Arabia
facility: Faizan Kashoo
state: Riyadh
city: Riyadh
country: Saudi Arabia
facility: Faizan Kashoo
Study officials:
References: