The Efficacy of Cathodal tDCS in ADHD

NCT03955692 | Completed

• 1 other identifier: MU-IRB 2017/046.2002
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effectiveness of five sessions of cathodal tDCS over the left DLPFC on inhibitory control/response inhibition in children and adolescents with ADHD. Investigators hypothesize that multiple sessions of cathodal tDCS will induce a greater and long-term effect on inhibitory response in children and adolescents with ADHD.

Conditions

ADHD

Outcome Measures

Primary Outcomes (6)

• Change of accuracy rate

  Accuracy rate from go/no-go tasks

  Change from baseline to Day 0 after tDCS (T1)

• Change of accuracy rate

  Accuracy rate from go/no-go tasks

  Change from Day 0 to 1 week after tDCS (T2)

• Change of accuracy rate

  Accuracy rate from go/no-go tasks

  Change form 1 week to 1 month after tDCS (T3)

• Change in the amplitude of ERP recording

  The amplitude of the ERP components (N2 and P3) in average will be use as outcome measures to evaluate response inhibition.

  Change from baseline to Day 0 after tDCS (T1)

• Change in the amplitude of ERP recording

  The amplitude of the ERP components (N2 and P3) in average will be use as outcome measures to evaluate response inhibition.

  Change from Day 0 to 1 week after tDCS (T2)

• Change in the amplitude of ERP recording

  The amplitude of the ERP components (N2 and P3) in average will be use as outcome measures to evaluate response inhibition.

  Change form 1 week to 1 month after tDCS (T3)

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Cathodal tDCS will be applied over the left DLPFC (F3) according to the 10-20 EEG electrode systems and the anode will be placed over the right supraorbital (Fp2), using rectangular saline-soaked sponge pads 35 cm2. The current intensity of 1.5 mA will be used for 15 mins for a session.

Device: tDCS

Sham tDCS

SHAM COMPARATOR

Cathodal tDCS will be applied over the left DLPFC (F3) according to the 10-20 EEG electrode systems and the anode will be placed over the right supraorbital (Fp2), using rectangular saline-soaked sponge pads 35 cm2. The current intensity of 1.5 mA will flow continuously only 120 seconds. The electrode will be attached until the end of stimulation even the current flows only at the beginning.

Device: tDCS

Interventions

tDCS DEVICE

Five sessions (active/sham) will be held on five consecutive days. The parameter of electrode size, current strength and current duration were previously tested for safety in children

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents aged 7 to 16 years with suspected ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5TM). Diagnostic confirmation will be performed by pediatric neurologist or psychologist.
• Right-handed
• Free of any neurological antecedent, unstable medical conditions such as epilepsy; although tDCS is believed to induce very less or no risk of seizure and epileptic seizure have never been reported in tDCS study even in a study with active epilepsy.

You may not qualify if:

• Be unable to understand the instruction
• No clear neurological antecedent history
• Presence of intracranial metal implantation, cochlea implant, or cardiac pacemaker
• Motor or perceptual handicap that would prevent using the computer program
• For patients who under medication, poor-adjusted to their medication, type and dosage of medication is changed less than 4 weeks prior to the start
• Subjects are participating in the other protocol or receiving alternative treatment such transcranial magnetic stimulation.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty ofPhysical Therapy, Mahidol University

Salaya, Nakonpathom, 73170, Thailand

Location

Related Publications (1)

• Klomjai W, Siripornpanich V, Aneksan B, Vimolratana O, Permpoonputtana K, Tretriluxana J, Thichanpiang P. Effects of cathodal transcranial direct current stimulation on inhibitory and attention control in children and adolescents with attention-deficit hyperactivity disorder: A pilot randomized sham-controlled crossover study. J Psychiatr Res. 2022 Jun;150:130-141. doi: 10.1016/j.jpsychires.2022.02.032. Epub 2022 Mar 2.

  PMID: 35367657 DERIVED

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

• Wanalee Klomjai, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: May 20, 2019
• Study Start: December 15, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)