Infantile HemiplegiaNCT04278430
Transcranial Direct Current Stimulation for Attention Deficit
A study testing transcranial direct current stimulation in people with Infantile Hemiplegia, run by Majmaah University.
Trial summary
Infantile hemiplegia due to brain injury is associated with poor attention. Left-sided infantile hemiplegia affects the learning and acquisition of new skills. This study is aiming to improve the Selective visual attention (SVA) through transcranial direct current stimulation (tDCS) in children with Left-sided… Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Infantile Hemiplegia
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2017to 15 Feb 2019
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 8-15 years
- Left-sided infantile hemiplegia
- lesion to non-dominant hemisphere
Who cannot join
- History of epilepsy
- second stroke
- color blind
- under medication for psychiatric illness
About this study
Official title: Does Transcranial Direct Current Stimulation Affect Selective Visual Attention in Children With Left-sided Infantile Hemiplegia? A Preliminary Randomized Controlled Study
Infantile hemiplegia due to brain injury is associated with poor attention. Left-sided infantile hemiplegia affects the learning and acquisition of new skills. This study is aiming to improve the Selective visual attention (SVA) through transcranial direct current stimulation (tDCS) in children with Left-sided infantile hemiplegia .
Read the detailed description
Infantile hemiplegia (IH) refers to brain injuries that occur before or at birth and lead to hemiplegia/ total paralysis of one side of the body, including the face, arm and leg. The IH is quit rare condition and occurs in 1 in 1000 live births. however, the condition is reported to cause functional and cognitive disability. Children with IH suffer from poor attention particularly visual attention, that is essential to be understand the written language. A focused reading is essential in learning and children with IH possess moderate intelligence and attend school.
Transcranial direct current stimulation(tTCS) is a novel intervention that use small amplitude electrical currents to stimulate the essential areas of the brain through surface electrodes placed on the corresponding areas of the brain.
The eligible children were divided into two groups. one group received tDCS with visual attention activities and the second group received sham tDCS with similar activities. The effect will be assessed before and after with Strops-color testing and a academic reading test.
The experiment intends to explore the affect of tTCS on visual attention span among children with Left-sided infantile hemiplegia.
- Conditions
- Infantile Hemiplegia
- Being tested
- transcranial direct current stimulation, Sham tDCS
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
The tDCS stimulator (ActivaDose II tDCS Device; IOMED Inc., Salt Lake City, USA) is a standardized instrument used and tested in children. Two tDCS electrodes of dimensions 3" x 3" were used for the brain stimulation. The electrodes were inserted into a wet saline sponge.
Sham tDCSDevice
Five children with LSIH were randomly allocated to this group. All participants received sham tDCS for 3 weeks on alternate days and completed 10 treatment sessions. The sham tDCS followed preparatory procedures similar to that used for the experimental group, except that the device was disconnected after the initial increase of the current. Children usually started the activity without noticing that the device was disconnected. The children were assessed at baseline, during the 5th and 10th sessions, and during a follow-up that was scheduled for 4 months later.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS group | Experimental | The tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 1.5 mA intensity Receives: Device: transcranial direct current stimulation |
| Sham tDCS | Sham comparator | The tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 0 mA intensity. Receives: Device: Sham tDCS |
| Control | Active comparator | The normal heathy children age matched undergo the same activity and brain stimulation as the real tDCS group. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Computerized Stroop Color-Word Test
The Computerized Stroop Color-Word Test consists of two phases.The first phase is the preparation phase, where the children are asked to identify the color of a circle on the monitor (red, blue, green, or yellow) and press the corresponding key on the keyboard using the unaffected side. Scores obtained at this stage were not included in the final results. The second phase is the actual test, which consists of 96 colorful words, divided into 48 correctly matched colorful words and 48 incorrectly matched colorful words. The words that appeared on the computer screen were presented in a randomized sequence. Each word appeared on the computer screen for 2000 ms with an 800-ms interval. The children were asked to identify the color of the words regardless of their meanings.
Measured: 3 weeks
Secondary outcomes (1)
academic practical test
An academic practical test will be needed to evaluate the improvement in SVA among children. Therefore, a reading comprehension test will be added to the outcome variables. All the three groups performed a reading comprehension test at the baseline, during the 5th and 10th sessions, and during the follow-up period. Two different stories (unread before and equal difficulty) will be selected from their English course and presented to them at the start and following the completion of the 10th session. These stories comprised of between 700 and 1000 words and the time allowed to complete the story was 20 minutes. In the end, the children were asked to answer 10 multiple-choice questions (MCQ) related to the story. Each correct answer will be assigned 1 point.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start3 Jan 2017
- Primary completion14 Jan 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile HemiplegiaStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, faizan kashoo, PT, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278430
- Sponsor's protocol ID
- MU-1441-78
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Data sharing depends on the permission from the parents of the children and research team.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Transcranial Direct Current Stimulation Affect Selective Visual Attention in Children With Left-sided Infantile Hemiplegia? A Preliminary Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04278430
- Acronym / sponsor ID
- MU-1441-78
- Conditions
- Infantile Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 20 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.
Infantile hemiplegia due to brain injury is associated with poor attention. Left-sided infantile hemiplegia affects the learning and acquisition of new skills. This study is aiming to improve the Selective visual attention (SVA) through transcranial direct current stimulation (tDCS) in children with Left-sided infantile hemiplegia .
Detailed description
Infantile hemiplegia (IH) refers to brain injuries that occur before or at birth and lead to hemiplegia/ total paralysis of one side of the body, including the face, arm and leg. The IH is quit rare condition and occurs in 1 in 1000 live births. however, the condition is reported to cause functional and cognitive disability. Children with IH suffer from poor attention particularly visual attention, that is essential to be understand the written language. A focused reading is essential in learning and children with IH possess moderate intelligence and attend school.
Transcranial direct current stimulation(tTCS) is a novel intervention that use small amplitude electrical currents to stimulate the essential areas of the brain through surface electrodes placed on the corresponding areas of the brain.
The eligible children were divided into two groups. one group received tDCS with visual attention activities and the second group received sham tDCS with similar activities. The effect will be assessed before and after with Strops-color testing and a academic reading test.
The experiment intends to explore the affect of tTCS on visual attention span among children with Left-sided infantile hemiplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real tDCS group | Experimental | Device: transcranial direct current stimulationThe tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 1.5 mA intensity |
| Sham tDCS | Sham comparator | Device: Sham tDCSThe tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 0 mA intensity. |
| Control | Active comparator | Device: transcranial direct current stimulationThe normal heathy children age matched undergo the same activity and brain stimulation as the real tDCS group. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 8-15 years
- Left-sided infantile hemiplegia
- lesion to non-dominant hemisphere
Key exclusion criteria (4 listed)
- History of epilepsy
- second stroke
- color blind
- under medication for psychiatric illness
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 |
|---|---|---|
| transcranial direct current stimulationThe tDCS stimulator (ActivaDose II tDCS Device; IOMED Inc., Salt Lake City, USA) is a standardized instrument used and tested in children. Two tDCS electrodes of dimensions 3" x 3" were used for the brain stimulation. The electrodes were inserted into a wet saline sponge. | Device | Control, Real tDCS group |
| Sham tDCSFive children with LSIH were randomly allocated to this group. All participants received sham tDCS for 3 weeks on alternate days and completed 10 treatment sessions. The sham tDCS followed preparatory procedures similar to that used for the experimental group, except that the device was disconnected after the initial increase of the current. Children usually started the activity without noticing that the device was disconnected. The children were assessed at baseline, during the 5th and 10th sessions, and during a follow-up that was scheduled for 4 months later. | Device | Sham tDCS |
Primary outcome
The Computerized Stroop Color-Word Test
Time frame: 3 weeks
The Computerized Stroop Color-Word Test consists of two phases.The first phase is the preparation phase, where the children are asked to identify the color of a circle on the monitor (red, blue, green, or yellow) and press the corresponding key on the keyboard using the unaffected side. Scores obtained at this stage were not included in the final results. The second phase is the actual test, which consists of 96 colorful words, divided into 48 correctly matched colorful words and 48 incorrectly matched colorful words. The words that appeared on the computer screen were presented in a randomized sequence. Each word appeared on the computer screen for 2000 ms with an 800-ms interval. The children were asked to identify the color of the words regardless of their meanings.
1 secondary outcome
academic practical test
Time frame: 3 weeks
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 25 Feb 2020.
- Individual participant dataSharing planned: Undecided. The Data sharing depends on the permission from the parents of the children and research team.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Infantile Hemiplegia, run by Majmaah University.
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 3 inclusion and 4 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The Computerized Stroop Color-Word Test (time frame: 3 weeks). 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 25 Feb 2020.