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Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD) (STIMADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder, Transcranial Direct Current Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Transcranial Direct Current Stimulation

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers
  • Children, male or females presenting a sufficient compliance for participate aged 7-14 years at the time of Visit 1 (Enrolment/baseline).
  • Children's parent or legally authorised representative must sign informed consent. The children must sign assent if applicable (depending of age and understanding). The principal investigator of the center where the child is included signs the document, certifying that the family and the child, or their authorised representative, have received informed consents.
  • Children meet DSM-5 criteria for ADHD (combined presentation) based on a clinical evaluation using questionnaire ADHD-Rating-Scale (ADHD-RS) and the Kiddie Schedule for Affective Disorders and Schizophrenia French version (Kiddie-SADS).
  • Subjects have a minimum ADHD-RS total score of 32 at Visit 1.
  • Children have a minimum CGI of 4 at Visit 1.
  • Children have an age-appropriate intellectual level evaluated with WISC-5 (Full IQ >80).
  • Children in which stimulant medication have been tested previously and stopped for adverse effects could be included in the study after a wash out of at least seven days.

Exclusion Criteria:

  • Children have a neurological pathology or handicap: Epilepsy, cerebral palsy, sequelae of brain injury (traumatic or ischemic or inflammatory...)
  • Children have a comorbid psychiatric disorder: conduct disorders, autism, severe obsessive-compulsive disorder, mood disorder, bipolar illness, conduct disorder, psychosis, and substance abuse.
  • Children under medication (stimulant or other psychotropic treatment, benzodiazepine, antidepressant, hypnotics and melatonin) or who did not respond previously to stimulant will not be included.
  • Severe sleep disorder.
  • Contraindication to tDCS.

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tDCS

Sham

Arm Description

Outcomes

Primary Outcome Measures

Variation of ADHD-RS(ADHD Rating Scale-IV) between both arms
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. How to Score For inattention (IA) subscale raw score: Add the odd-numbered items For hyperactivity-impulsivity (HI) subscale raw score: Add the even-numbered items To obtain the total raw score: Add the IA and Hi subscale raw scores Convert the raw scores to percentile scores by using the appropriate scoring profile provided on the back of the rating scale.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2021
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
CHU LYON, Nantes University Hospital, Centre Hospitalier Charles Perrens, Bordeaux, University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04704687
Brief Title
Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Acronym
STIMADHD
Official Title
Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
CHU LYON, Nantes University Hospital, Centre Hospitalier Charles Perrens, Bordeaux, University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurodevelopmental disorder in childhood. Patients with ADHD present inattention, impulsivity and hyperactivity causing severe impairments on academic achievement, social and professional life and daily functioning. Medications are effective in a majority of children with ADHD, but about 30% do not respond or tolerate stimulants, and some parents refuse pharmacological treatments.Transcranial Direct Current Stimulation is a safe and non-invasive technique of brain stimulation used in several neurological and psychiatric disorders, and recently in ADHD. In patients with ADHD, tDCS stimulations targeted frontal regions improve executive and attentional functioning and daily life symptoms. The objective of this project is to evaluate the efficacy of tDCS (vs sham) during cognitive-remediation exercises on ADHD symptoms (inattention, impulsivity and hyperactivity as defined by DSM-5) in children with ADHD between 7 and 14 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Transcranial Direct Current Stimulation
Keywords
Attention Deficit Hyperactivity Disorder, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS
Arm Type
Experimental
Arm Title
Sham
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
Children will perform two successive interventions composed each by a set of 15 sessions of effective-tDCS combine with cognitive-training exercises.
Primary Outcome Measure Information:
Title
Variation of ADHD-RS(ADHD Rating Scale-IV) between both arms
Description
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. How to Score For inattention (IA) subscale raw score: Add the odd-numbered items For hyperactivity-impulsivity (HI) subscale raw score: Add the even-numbered items To obtain the total raw score: Add the IA and Hi subscale raw scores Convert the raw scores to percentile scores by using the appropriate scoring profile provided on the back of the rating scale.
Time Frame
at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Children, male or females presenting a sufficient compliance for participate aged 7-14 years at the time of Visit 1 (Enrolment/baseline). Children's parent or legally authorised representative must sign informed consent. The children must sign assent if applicable (depending of age and understanding). The principal investigator of the center where the child is included signs the document, certifying that the family and the child, or their authorised representative, have received informed consents. Children meet DSM-5 criteria for ADHD (combined presentation) based on a clinical evaluation using questionnaire ADHD-Rating-Scale (ADHD-RS) and the Kiddie Schedule for Affective Disorders and Schizophrenia French version (Kiddie-SADS). Subjects have a minimum ADHD-RS total score of 32 at Visit 1. Children have a minimum CGI of 4 at Visit 1. Children have an age-appropriate intellectual level evaluated with WISC-5 (Full IQ >80). Children in which stimulant medication have been tested previously and stopped for adverse effects could be included in the study after a wash out of at least seven days. Exclusion Criteria: Children have a neurological pathology or handicap: Epilepsy, cerebral palsy, sequelae of brain injury (traumatic or ischemic or inflammatory...) Children have a comorbid psychiatric disorder: conduct disorders, autism, severe obsessive-compulsive disorder, mood disorder, bipolar illness, conduct disorder, psychosis, and substance abuse. Children under medication (stimulant or other psychotropic treatment, benzodiazepine, antidepressant, hypnotics and melatonin) or who did not respond previously to stimulant will not be included. Severe sleep disorder. Contraindication to tDCS.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick BERQUIN, Pr
Phone
(33)3 22 08 76 70
Email
berquin.patrick@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick BERQUIN, Pr
Phone
(33)3 22 08 76 70
Email
berquin.patrick@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Pierre FOURNERET, MD
First Name & Middle Initial & Last Name & Degree
Emmanuel POULET, MD
First Name & Middle Initial & Last Name & Degree
Olivier BONNOT, MD
First Name & Middle Initial & Last Name & Degree
Anne SAUVAGET, MD
First Name & Middle Initial & Last Name & Degree
Manuel BOUVARD, MD
First Name & Middle Initial & Last Name & Degree
Renaud JARDRI, MD
First Name & Middle Initial & Last Name & Degree
Laurent QUERNE, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

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