Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Attention Deficit Hyperactivity Disorder (ADHD) - Parents |
The questionnaire, a standardized instrument to diagnose ADHD, provides a severity score for each ADHD symptom, and is characterized by psychometric properties that allow detection of changes even in the very brief window of time such as only 1 week. Usually, 0 means never, and 3 or 4 means very often and the higher the score, the more severe the symptom. |
Change form baseline to week 1 to week 2 to week 3 to week 4 to 1 week post treatment to 1 month post treatment |
|
| Primary |
Disruptive Behavior Disorders Rating (DBD) - Parents |
The Disruptive Behavior Disorder rating scale is designed to aid in the diagnostic process for a number of child psychopathologies, particularly externalizing disorders, including the three disruptive behavior disorder categories (Conduct Disorder, Oppositional Defiance Disorder and Attention Deficit Hyperactivity Disorder). Each item is rated on a four-point scale ranging from not at all (0) to very much (3). |
Change form baseline to week 1 to week 2 to week 3 to week 4 to 1 week post treatment to 1 month post treatment |
|
| Primary |
Visual Analogue Scale (VAS) - Teachers |
Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scores are recorded by stopping the slider on a 10-cm line that represents a continuum between "absent" and "present."Teachers will also be asked to weekly complete horizontal VAS on attention, work independence, motor unrest, impulsivity, keeping appointments, order, playground behavior. |
Change form baseline to week 1 to week 2 to week 3 to week 4 to 1 week post treatment to 1 month post treatment |
|
| Primary |
Visual Search - Child |
Visual Search a measures a conjunction visual search process. Reaction time (RT) and accuracy are dependent on the distractor-ratio and the number of distractors present. |
Change form baseline to week 1 to week 2 to week 3 to week 4 to 1 week post treatment to 1 month post treatment |
|
| Primary |
Stroop Task - Child |
The Stroop task is measure of interference control. The proportion of false answer and reaction time of third stage as the main stage that shows interference stimuli was calculated to assess the interference inhibition. |
Change form baseline to week 1 to week 2 to week 3 to week 4 to 1 week post treatment to 1 month post treatment |
|
| Primary |
Go/No Go Task - Child |
The Go/No Go Task is a measure of prepotent response inhibition. The correct response to No-Go stimuli assesses the prepotent response inhibition in a way that they have to refrain from pressing the arrow button when they see a Stop sign with delay. |
Change form baseline to week 1 to week 2 to week 3 to week 4 to 1 week post treatment to 1 month post treatment |
|
| Primary |
Stop Signal Task - Child |
The Stop Signal Task is another measure of inhibition of prepotent responses. The stop signal reaction time (SSRT), a measure of inhibition, is estimated based on the notion of a race between a go process, which is triggered by the presentation of the go stimulus, and a stop process, which is triggered by the presentation of the stop signal. |
Change form baseline to week 1 to week 2 to week 3 to week 4 to 1 week post treatment to 1 month post treatment |
|
| Secondary |
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of home-based tDCS in children with ADHD |
Frequency of premature study terminations between patients randomized to tDCS versus those randomized to sham treatment, the safety of tDCS by comparing the severity and frequency of serious adverse events (AEs), treatment-emergent AEs, and total AEs during each visit, the number of days the child/parents decide to stay medication free post tDCS treatment for maximal 1 month will also be carefully recorded. Children and parents will also report feasibility using a visual analogue scale (VAS). |
From Start to treatment termination |
|
| Secondary |
Hospital Anxiety and Depression Scale (HADS) - Children |
To evaluate the effect of home-based tDCS on secondary ADHD symptoms, i.e., depression and anxiety, in children with ADHD. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. |
Change form baseline to week 1 to week 2 to week 3 to week 4 to 1 week post treatment to 1 month post treatment |
|
| Secondary |
Inventory of Depressive Symptomatology Clinician (IDS-C) - Parents |
To evaluate the effect of home-based tDCS on secondary ADHD symptoms, i.e., depression and anxiety, in children with ADHD. The IDS-C total scores range from 0 to 27. The total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes. Each item is rated 0-3. |
Change form baseline to week 1 to week 2 to week 3 to week 4 to 1 week post treatment to 1 month post treatment |
|
| Secondary |
Hemodynamic Response |
Changes in oxygenated hemoglobin (oxy-Hb), deoxygenated hemoglobin (deoxy-Hb), and total hemoglobin (total-Hb) concentration changes will be calculated with the modified Beer-Lambert Law using the NIRSIT-Lite Kids functional Near-Infrared spectroscopy device made by OBELAB Inc. The device radiates a Light Emitting Diode (LED) light with an output of 1 milliwatt (mW) or less which is harmless to the human body. The device comes with PC software that can be used to monitor the distribution of cerebral oxygen saturation via multiple channels (OBELAB Inc.). |
Baseline to 1 Week post tDCS to 1 Month Post tDCS |
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