Home-Based tDCS in Children With ADHD: A Randomized, Sham-Controlled tDCS and fNIRS Study
NCT04634006, Not applicable, Unknown, Onze Lieve Vrouw Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Home-Based tDCS in Children With ADHD: A Randomized, Sham-Controlled tDCS and fNIRS Study | ClinicalTrials.gov |
| NCT number | NCT04634006 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 75 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Onze Lieve Vrouw Hospital | ClinicalTrials.gov |
| Conditions | Attention Deficit Hyperactivity Disorder (ADHD), Attention Deficit Disorder (ADD) | ClinicalTrials.gov |
| Interventions | Home-based transcranial direct current (tDCS) device | ClinicalTrials.gov |
| First posted | 2020-11-18 | ClinicalTrials.gov |
| Last updated | 2020-11-18 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Attention Deficit Hyperactivity Disorder (ADHD) - Parents | 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 | 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. | ClinicalTrials.gov |
| Primary | Disruptive Behavior Disorders Rating (DBD) - Parents | 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 | 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). | ClinicalTrials.gov |
| Primary | Visual Analogue Scale (VAS) - Teachers | 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 | 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. | ClinicalTrials.gov |
| Primary | Visual Search - Child | 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 | 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. | ClinicalTrials.gov |
| Primary | Stroop Task - Child | 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 | 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. | ClinicalTrials.gov |
| Primary | Go/No Go Task - Child | 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 | 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. | ClinicalTrials.gov |
| Primary | Stop Signal Task - Child | 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 | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of home-based tDCS in children with ADHD | From Start to treatment termination | 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). | ClinicalTrials.gov |
| Secondary | Hospital Anxiety and Depression Scale (HADS) - Children | 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 | 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. | ClinicalTrials.gov |
| Secondary | Inventory of Depressive Symptomatology Clinician (IDS-C) - Parents | 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 | 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. | ClinicalTrials.gov |
| Secondary | Hemodynamic Response | Baseline to 1 Week post tDCS to 1 Month Post tDCS | 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.). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Go/No-Go Task | Primary outcome | ConductCognition |
| Stop-Signal Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)