Cerebral Palsy InfantileNCT04257981
Effect of Transcranial Direct Current Stimulation on Upper Extremity of Children With Hemiparesis
A study testing Brain stimulator v3.0 in people with Cerebral Palsy Infantile, run by Majmaah University at 2 sites in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy Infantile
- What is being tested?
- Brain stimulator v3.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 3 Jan 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Hemorrhage in the subarachnoid space
- Aphasia
- Neurosurgery of brain
- Seizures in the past 12 months.
- On medication for seizures.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Faizan Kashoo
Riyadh, Riyadh Region, 15341
Faizan Kashoo
Riyadh, 11952
About this study
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
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.
Read the 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
- Being tested
- Brain stimulator v3.0, Sham Comparator: Control group
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain stimulator v3.0Device
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
Sham Comparator: Control groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Comparator: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Months
Secondary outcomes (2)
Beiseline and post- intervention Motricity Index
: Motricity Index (MI) upper limb items will be used to evaluate upper limb strength. The tool is found valid and reliable20 in scoring upper limb strength in stroke patients.
Measured: 8 Months
Baseline and post- intervention Modified Barthel Index
Modified Barthel Index (BI) is a valid tool21 to measure functional disability in neurological disability to evaluate the functional disability. The scale will take 45 minutes to administer.
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start3 Jan 2020
- Primary completion1 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Collaborators
- Shiekh Abdullah Al-Twejeri Research Chair for Stroke
- Responsible party
- Principal investigator, faizan kashoo, PT, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257981
- Sponsor's protocol ID
- MU/RBI/346754/1-3-2020
- Status last verified
- Sep 2020
- First submitted
- 3 Feb 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared by the authors upon request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04257981
- Acronym / sponsor ID
- MU/RBI/346754/1-3-2020
- Conditions
- Cerebral Palsy Infantile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Collaborators
- Shiekh Abdullah Al-Twejeri Research Chair for Stroke
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Brain stimulator v3.0Transcranial 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. |
| Control group | Sham comparator | Other: Sham Comparator: Control groupSham 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Hemorrhage in the subarachnoid space
- Aphasia
- Neurosurgery of brain
- Seizures in the past 12 months.
- On medication for seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain stimulator v3.0Brain 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 | Device | Experimental group |
| Sham Comparator: Control groupThe 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 | Control group |
Primary outcome
Baseline and post- intervention Fugl-Meyer motor assessment
Time frame: 8 Months
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.
2 secondary outcomes
Beiseline and post- intervention Motricity Index
Time frame: 8 Months
Baseline and post- intervention Modified Barthel Index
Time frame: 8 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No. Data will be shared by the authors upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain stimulator v3.0 in people with Cerebral Palsy Infantile, run by Majmaah University at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline and post- intervention Fugl-Meyer motor assessment (time frame: 8 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.