Transcranial Direct Current Stimulation for Attention Deficit

NCT04278430 | Completed DMC

• 1 other identifier: MU-1441-78
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Infantile Hemiplegia

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks

Secondary Outcomes (1)

• academic practical test

  3 weeks

Study Arms (3)

Real tDCS group

EXPERIMENTAL

The tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 1.5 mA intensity

Device: transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

The tDCS applied over dorsolateral prefrontal cortex for 20 minutes with 0 mA intensity.

Device: Sham tDCS

Control

ACTIVE COMPARATOR

The normal heathy children age matched undergo the same activity and brain stimulation as the real tDCS group.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

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.

Control; Real tDCS group

Sham tDCS DEVICE

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.

Sham tDCS

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 8-15 years
• Left-sided infantile hemiplegia
• lesion to non-dominant hemisphere

You may not qualify if:

• History of epilepsy
• second stroke
• color blind
• under medication for psychiatric illness

Sponsors & Collaborators

• Majmaah University: lead

MeSH Terms

Conditions

Hemiplegia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The care provider were masked and the pre-post testing was performed by different therapist unaware of the assignment of children.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: January 3, 2017
• Primary Completion: January 14, 2019
• Study Completion: February 15, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02