MedDataX Logo

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

NCT ID: NCT04634006

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

BACKGROUND: Attention deficit/hyperactivity disorder (ADHD) is one of the most impairing neurodevelopmental disorders of childhood with a worldwide prevalence of 5.3% in children. It is featured by the presence of a persistent pattern of inattention and/or hyperactivity-impulsivity that profoundly affects or reduces the quality of social, academic, and occupational achievements. Influential models of ADHD mainly focus on a deficit in inhibitory control that leads to executive dysfunctions, associated to neural alteration in the prefrontal areas, the striatum, and the cerebellum. Although ADHD can be effectively treated with psychostimulants, a significant proportion of patients discontinue treatment because of adverse events or insufficient improvement of symptoms. In addition, cognitive abilities that are frequently impaired in ADHD are not directly targeted by medication. Therefore, additional treatment options, especially to improve cognitive abilities, are needed. Because of its relatively easy application and well-established safety, non-invasive brain stimulation, such as transcranial direct current stimulation (tDCS), is a promising additional treatment option for children with ADHD. To date, only eight studies have submitted children with ADHD to a maximal of 5 daily sessions. The fact that the technology is inexpensive, and has the potential of being used as a portable device at home by patients, further renders tDCS an attractive tool to explore in treatment in children with neuropsychological disorders, including ADHD. Further, functional near infrared spectroscopy (fNIRS), a non-invasive, compact, unrestrictive, and accessible functional neuroimaging modality has demonstrated its potential in the clinical diagnosis of ADHD children. Since fNIRS visualizes the neural attention and inhibition processes in children with ADHD while they perform tasks online, this technique may have great potential in recording neural changes by tDCS.

OBJECTIVES: The investigators aim to explore the acute and long-term effect of 20 daily sessions of home-based tDCS while doing homework. Our primary objectives seek to determine if tDCS improves: 1) ADHD symptoms, 2) executive function and/or inhibitory processes in children with tDCS. Our secondary aims look at 1) depressive and anxiety symptoms in children with ADHD and 2) the safety and feasibility of home-based tDCS in children with ADHD, and 3) evaluate the mechanisms through which tDCS could be therapeutic using fNIRS that reveals neuroplastic changes successfully.

METHODS: 75 children with ADHD will be submitted to a home-based active or sham fixed-dose tDCS (20 minutes of 1 mA) in a 1:1:1 double-blind, sham-controlled, randomized, parallel-group scheme. Children will be randomly assigned to receiving either 1) active tDCS of anodal left DLPFC and cathodal vertex, 2) active tDCS of anodal right IFG and cathodal posterior to left mastoid or 3) sham tDCS. Stimulation sessions will occur daily, Monday through Friday, for 20 days over a 4-week period. To determine the acute and longterm efficacy of home-based tDCS, children, parents, and teachers will be asked to weekly fill in questionnaires and/or perform tasks online on the weekend from their home. 1) ADHD symptoms will be evaluated using ADHD, DBD and VAS scales. Executive function and inhibitory processes will be determined by a change in I) Visual Search Task, II) Stroop Task, III) Go/No Go Task, IV) Stop Signal Task. 2) Depression/anxiety symptoms will be assessed using HADS and IDS-C scales. Safety and feasibility of home-based tDCS will be assessed using VAS scales and an adverse events questionnaire. Lastly, a change in oxygenated hemoglobin and deoxygenated hemoglobin will help elucidate the mechanisms of tDCS on ADHD. After the tDCS intervention, children will be asked to stay medication-free for as long as they can until study completion for maximal 1-month-post tDCS. All children will be evaluated in person at baseline (visit 1), immediately after the 4-week-treatment (visit 2), and a last visit within 1 month after treatment (visit 3). During these three visits, brain activation patterns of the children will be assessed online using fNIRS while performing the four behavioral tasks.

CONCLUSION: This study will be the first to increase the number of daily sessions of tDCS from 5 to 20 in children with ADHD, making it more than 5 times more likely to increase the response rate to tDCS. Knowledge gained by non-invasive brain stimulation (NIBS) research in children with ADHD might be translatable into an alternative effective treatment, reduce side-effects, and advance the development of closed-loop neuromodulation in ADHD in general. Additionally, no home-based remote tDCS study has ever been conducted in children. Demonstrating its potential will not only offer a more feasible alternative to daily laboratory visits or clinical consultations but may also reduce patient and clinic costs. Lastly, this study will be the first combining fNIRS and tDCS in order to elucidate the acute and longterm mechanisms of effective tDCS intervention in children with ADHD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, sham-controlled, parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

active tDCS 1

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)

Group Type ACTIVE_COMPARATOR

Home-based transcranial direct current (tDCS) device

Intervention Type 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 2

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)

Group Type ACTIVE_COMPARATOR

Home-based transcranial direct current (tDCS) device

Intervention Type 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.

sham tDCS

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.

Group Type SHAM_COMPARATOR

Home-based transcranial direct current (tDCS) device

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 6-12,
2. ADHD without comorbid conduct disorders, autism or tic disorders as diagnosed according to guidelines by an experienced child and adolescent psychiatrist,
3. Medication satisfaction VAS (\<6/10),
4. Sufficient compliance of the child and his/her family,
5. 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),
6. Right-handed

Exclusion Criteria

1. Intelligence Quotient (IQ) \<80,
2. Other neuropsychiatric or pediatric disorders,
3. 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,
4. Any metallic implantations in the facial or skull area, cochlear implant, pacemaker.
5. History of exposure to tDCS in the past (to minimizing risk of unblinding sham condition).
6. History of exposure to Electroconvulsive therapy in the past.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Onze Lieve Vrouw Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Choi Deblieck

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Choi Deblieck, PhD

Role: PRINCIPAL_INVESTIGATOR

UPC KU Leuven

Liesbet Devalkeneer, MD

Role: PRINCIPAL_INVESTIGATOR

OLVZ Asse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

OLVZ Asse

Asse, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Choi Deblieck, PhD

Role: CONTACT

Phone: +32473871223

Email: [email protected]

Liesbet Devalkeneer, MD

Role: CONTACT

Phone: +32474370834

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Choi Deblieck, PhD

Role: primary

Liesbet Devalkeneer, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020/056

Identifier Type: -

Identifier Source: org_study_id