Home-Based tDCS in Children With ADHD: A Randomized, Sham-Controlled tDCS and fNIRS Study

NCT04634006 | Unknown DMC FDA Device

• 1 other identifier: 2020/056
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy of twenty daily sessions of home-based tDCS over the left DLPFC, right IFG on attention and response inhibition in children with ADHD. Investigators hypothesize that multiple sessions of tDCS will induce a greater and long-term effect on attentional and/or inhibitory response in children with ADHD. In addition, this study seeks to get a better understanding of the mechanisms of tDCS using fNIRS.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD); Attention Deficit Disorder (ADD)

Keywords

tDCS; fNIRS; home-based; Executive functioning; Attention; Inhibitory control; DLPFC; IFG; Children

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of home-based tDCS in children with ADHD

  From Start to treatment termination

• 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

• 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

• Hemodynamic Response

  Baseline to 1 Week post tDCS to 1 Month Post tDCS

Study Arms (3)

active tDCS 1

ACTIVE COMPARATOR

Anodal tDCS will be applied over the left DLPFC (F3) according to the 10-20 EEG electrode systems and the cathode will be placed over the the vertex (Cz), using square saline-soaked sponge pads 25 cm2. The current intensity of 1 mA will be used for 20 mins for a session. (N=25)

Device: Home-based transcranial direct current (tDCS) device

active tDCS 2

ACTIVE COMPARATOR

Anodal tDCS will be applied over the right IFG (1/3 of the distance between F8 and C6) according to the 10-20 EEG electrode systems and the cathode will be placed posterior to left mastoid, using square saline-soaked sponge pads 25 cm2. The current intensity of 1 mA will be used for 20 mins for a session. (N=25)

Device: Home-based transcranial direct current (tDCS) device

sham tDCS

SHAM COMPARATOR

Anodal tDCS will be applied over the left DLPFC (N=13) or right IFG (N=12) according to the 10-20 EEG electrode systems and the cathode will be placed over vertex or posterior to left mastoid, respectively, using square saline-soaked sponge pads 25 cm2. Sham stimulation will be maintained for 19 min without current flow by increasing current for 30 s followed by a decrease for 30 s.

Device: Home-based transcranial direct current (tDCS) device

Interventions

Home-based transcranial direct current (tDCS) device DEVICE

tDCS is a brain electrostimulation technique that consists of applying a current of low intensity (between 1 and 2 mA) on the scalp via two electrodes in order to modify the cerebral activity of the stimulated zones. Twenty sessions (active/sham) will be self-administered by parent or caregiver on twenty consecutive business days. The parameter of electrode size, current strength and current duration were previously tested for safety in children. The investigators use the Soterix Medical tDCS devices of the home-based miniCT 1x1 type.

active tDCS 1; active tDCS 2; sham tDCS

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-12,
• ADHD without comorbid conduct disorders, autism or tic disorders as diagnosed according to guidelines by an experienced child and adolescent psychiatrist,
• Medication satisfaction VAS (\<6/10),
• Sufficient compliance of the child and his/her family,
• Combined or hyperactive-impulsive type according to DSM-V (American Psychiatric Association 1994)\] or for the hyperkinetic disorder according to ICD-10 (F90.0, International Classification of Diseases (ICD), 2010),
• Right-handed

You may not qualify if:

• Intelligence Quotient (IQ) \<80,
• Other neuropsychiatric or pediatric disorders,
• Epilepsy, including pathological Electroencephalography-patterns (e.g., increased neural excitability), former cerebral seizure, drug abuse, increased intracranial pressure, former craniocerebral injury accompanied by loss of consciousness,
• Any metallic implantations in the facial or skull area, cochlear implant, pacemaker.
• History of exposure to tDCS in the past (to minimizing risk of unblinding sham condition).
• History of exposure to Electroconvulsive therapy in the past.

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead

Study Sites (1)

OLVZ Asse

Asse, Vlaams-Brabant, 1730, Belgium

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Choi Deblieck, PhD

  UPC KU Leuven

  PRINCIPAL INVESTIGATOR

• Liesbet Devalkeneer, MD

  OLVZ Asse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Choi Deblieck, PhD

CONTACT

+32473871223; choi.deblieck@upckuleuven.be

Liesbet Devalkeneer, MD

CONTACT

+32474370834; liesbet.devalkeneer@olvz-aalst.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, sham-controlled, parallel assignment

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 18, 2020
• Study Start: November 5, 2020
• Primary Completion: November 1, 2021
• Study Completion: June 1, 2022
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)