Effect of Transcranial Direct Current Stimulation on Upper Extremity of Children With Hemiparesis

NCT ID: NCT04257981

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-03
• Study Completion Date: 2021-05-01

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.

Conditions

Cerebral Palsy Infantile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

Transcranial direct stimulation + virtual related group:

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 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.

Group Type: EXPERIMENTAL

Brain stimulator v3.0

Intervention Type: DEVICE

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

Control group

Sham Transcranial direct stimulation Group + virtual related group; 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.

Group Type: SHAM_COMPARATOR

Sham Comparator: Control group

Intervention Type: OTHER

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

Interventions

Brain stimulator v3.0

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

Intervention Type: DEVICE

Sham Comparator: Control group

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiekh Abdullah Al-Twejeri Research Chair for Stroke

UNKNOWN

Sponsor Role: collaborator

Majmaah University

OTHER

Sponsor Role: lead

Responsible Party

faizan kashoo, PT

Prinicipal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faizan Kashoo

Riyadh, Riyadh Region, Saudi Arabia

Faizan Kashoo

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

MU/RBI/346754/1-3-2020

Identifier Type: -

Identifier Source: org_study_id