Transcranial Direct Current Stimulation for Attention Deficit

NCT ID: NCT04278430

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2019-02-15

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.

Conditions

Infantile Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Real tDCS group

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

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: 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.

Sham tDCS

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

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type: 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.

Interventions

transcranial direct current stimulation

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

Sham tDCS

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Majmaah University

OTHER

Sponsor Role: lead

Responsible Party

faizan kashoo, PT

Prinicipal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MU-1441-78

Identifier Type: -

Identifier Source: org_study_id