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

NCT04634006 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-11-18

No results posted yet for this study

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)

Interventions

DEVICE

Home-based transcranial direct current (tDCS) 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.

Sponsors & Collaborators

  • Onze Lieve Vrouw Hospital

    lead OTHER

Principal Investigators

  • Choi Deblieck, PhD · UPC KU Leuven

  • Liesbet Devalkeneer, MD · OLVZ Asse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2021-11-30
Completion
2022-06-30
FDA Device
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04634006 on ClinicalTrials.gov