Transcranial Direct Current Stimulation for Attention Deficit
Primary Purpose
Infantile Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Infantile Hemiplegia
Eligibility Criteria
Inclusion Criteria:
- Age between 8-15 years
- Left-sided infantile hemiplegia
- lesion to non-dominant hemisphere
Exclusion Criteria:
- History of epilepsy
- second stroke
- color blind
- under medication for psychiatric illness
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
Real tDCS group
Sham tDCS
Control
Arm Description
The tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 1.5 mA intensity
The tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 0 mA intensity.
The normal heathy children age matched undergo the same activity and brain stimulation as the real tDCS group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04278430
First Posted
February 18, 2020
Last Updated
February 24, 2020
Sponsor
Majmaah University
1. Study Identification
Unique Protocol Identification Number
NCT04278430
Brief Title
Transcranial Direct Current Stimulation for Attention Deficit
Official Title
Does Transcranial Direct Current Stimulation Affect Selective Visual Attention in Children With Left-sided Infantile Hemiplegia? A Preliminary Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Majmaah University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Hemiplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The care provider were masked and the pre-post testing was performed by different therapist unaware of the assignment of children.
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real tDCS group
Arm Type
Experimental
Arm Description
The tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 1.5 mA intensity
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
The tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 0 mA intensity.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The normal heathy children age matched undergo the same activity and brain stimulation as the real tDCS group.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Computerized Stroop Color-Word Test
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
academic practical test
Description
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.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 8-15 years
Left-sided infantile hemiplegia
lesion to non-dominant hemisphere
Exclusion Criteria:
History of epilepsy
second stroke
color blind
under medication for psychiatric illness
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The Data sharing depends on the permission from the parents of the children and research team.
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Transcranial Direct Current Stimulation for Attention Deficit
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