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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
Majmaah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Hemiplegia

Eligibility Criteria

8 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 18, 2020
    Last Updated
    February 24, 2020
    Sponsor
    Majmaah University
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    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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