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

NCT04257981 | Completed DMC

• 1 other identifier: MU/RBI/346754/1-3-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy Infantile

Outcome Measures

Primary Outcomes (1)

• Baseline and post- intervention Fugl-Meyer motor assessment

  The Fugl-Meyer motor assessment (FM) will be the primary outcome measure. The scale is a reliable and valid measure for upper limb impairment among stroke patients19. The score ranges from 0-66, score less than 18 are considered severe to moderate functional impairment. The scale takes 20 minutes to complete.

  8 Months

Secondary Outcomes (2)

• Beiseline and post- intervention Motricity Index

  8 Months

• Baseline and post- intervention Modified Barthel Index

  8 Months

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Device: Brain stimulator v3.0

Control group

SHAM COMPARATOR

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.

Other: Sham Comparator: Control group

Interventions

Brain stimulator v3.0 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

Experimental group

Sham Comparator: Control group 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

Control group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Age 5-12 years.
• Able to understand simple commands.
• Normal vision or with corrected glass

You may not qualify if:

• Hemorrhage in the subarachnoid space
• Aphasia
• Neurosurgery of brain
• Seizures in the past 12 months.
• On medication for seizures.

Sponsors & Collaborators

• Majmaah University: lead
• Shiekh Abdullah Al-Twejeri Research Chair for Stroke: collaborator

Study Sites (2)

Faizan Kashoo

Riyadh, Riyadh Region, 15341, Saudi Arabia

Location

Faizan Kashoo

Riyadh, 11952, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Children will be randomly allocated to one of the two groups by the lottery method. The researcher involved in randomization will not be involved in the assessment or treatment of the participants. The participants and therapists will also be blinded about the subjects allocated to a group by assigning a unique random number to the participants. Pre and post assessment will be performed by the same therapist. The therapist involved in the treatment is blinded about the treatment received by other groups. Each participant will undergo 3 weeks of treatment, 4 days a week. The total number of treatment sessions for each participant will be 12. Each participant will be assessed on the baseline, 2nd week, 3rd week and on 8th week follow up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 6, 2020
• Study Start: January 3, 2020
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 18, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)