Non-invasive Brain Stimulation for Pediatric ADHD

NCT03104972 | Completed

• 1 other identifier: HMO-17-0180
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The possibility of influencing brain activity and steadily enhancing behavioral performance through external intervention has long fascinated neuroscientists. One of these techniques, transcranial electrical stimulation (tES), has received great interest. Transcranial electrical stimulation (tES) in the current research includes two types of stimulation: transcranial direct current stimulation (tDCS) and transcranial random noise stimulation (tRNS). The tES techniques involve the application of constant weak direct current (e.g. 1-2 mA) to the brain via skin-electrode interface, creating electric field that modulates neuronal activity. The safety profile of tES is excellent. Despite effective pharmacotherapy for ADHD there is a need for improvement of cognitive dysfunction and behavioral symptoms that are only inadequately covered by pharmacological or psycho-social interventions. Since ADHD is the most common neurodevelopmental disorder in childhood with significant negative lifetime outcomes, non-invasive brain stimulation methods have been investigated in childhood and adolescents neuropsychiatric disorders showing promising results. If tES is significantly effective for certain symptoms of ADHD, it may offer many advantages as a therapy. Treatment of ADHD with non-invasive brain stimulation has recently been reviewed in the medical literature, concluding that this technique seems to have efficacy in ADHD, however, standardized study protocols are needed to determine it. In this study we intend to further examine the efficacy of tDCS and tRNS for children with ADHD and its effect on ADHD symptoms, memory, executive functions, in a randomized controlled crossover study.

Conditions

ADHD

Keywords

ADHD; TRANS CRANIAL ELECTRIC STIMULATION

Outcome Measures

Primary Outcomes (1)

• ADHD Rating Scale (ADHD-RS) parameters

  Assessment before and after intervention

  4 weeks

Secondary Outcomes (3)

• Wechsler Intelligence Scale for Children (WISC-IV)

  4 weeks

• Behavior Rating Inventory of Executive Function (BRIEF)

  4 weeks

• MOXO-Continuous Performance Test standardized attention test

  4 weeks

Other Outcomes (2)

• Resting state Electroencephalography (EEG)

  4 weeks

• CGI-S Scale = Clinical Global Impression - Severity

  4 weeks

Study Arms (3)

tDCS - placebo

EXPERIMENTAL

tDCS-placebo (sham) group to receive either transcranial direct stimulation (tDCS) or matching placebo (sham( during 5 following days (one session each day). After a one week break, there will be a crossover between the control group and the sham group: those we received tDCS in the 1st week will get sham, while those who received sham in the 1st week will received tDCS at the 3rd week.

Device: tDCS; Device: sham

tRNS - placebo

EXPERIMENTAL

trans cranial random stimulation (tRNS)-sham group, who will receive the same type of intervention with the same intervals as above but with tRNS instead of tDCS.

Device: tRNS; Device: sham

tDCS-tRNS

EXPERIMENTAL

tDCS-tRNS group. Here the same intervention as above will be provided with the same intervals, but real tDCS and real tRNS will be provided in a counterbalanced fashion. This would allow to compare the different treatment in a within-subject design, as well as to compare the effect of those to sham stimulation in the first two groups in a between-subject design.

Device: tDCS; Device: tRNS

Interventions

tDCS DEVICE

Stimulation would be applied using semi-dry 5X5 cm electrodes. The current would be 0.75mA, which based on previous computational modeling of tDCS in children and is estimated to equal that of 1-1.5 mA in adults. This decision was made after considering the parameters that would influence current distribution and density at the site of stimulation such as thinner scalp, less cerebrospinal fluid, and smaller head size of the paediatric population. A similar dosage using tDCS was well tolerated by children, and was not associated with adverse effects29. The anodal electrode will be positioned above the dlPFC (F3 based on the International 10-20 system, while the cathodal electrode would be placed over the right supraorbital.

tDCS - placebo; tDCS-tRNS

tRNS DEVICE

Children in the active tRNS group will received 0.75mA of tRNS (100-640Hz) to their left dorsolateral prefrontal cortex (dlPFC) and the right inferior frontal gyrus (IFG) via semi-dry 5cm X 5cm electrodes, attached under designated electrode positions (F3, F8) of a tES cap that followed the International 10-20 system (InnoSphere Inc., Haifa). The left dlPFC and right IFG were chosen, based on their contribution in executive control and inhibition. tRNS will be applied for 20 minutes per session during an iPad cognitive training. Similar duration has also been used in paediatrics using tDCS29. Similar to a previous tRNS study in children, and the rational provided for tDCS we will apply 0.75mA.

tDCS-tRNS; tRNS - placebo

sham DEVICE

For sham-tRNS we will use the same montage as in active tRNS. For sham-tDCS we will use the same montage as in active tDCS. The only difference between active and sham tES would be that in the case of the sham tES the 30 sec of ramp up of the current from 0 to 0.75mA would not be followed by 19 min of stimulation at 0.75mA as in active tES, but would immediately be followed by 30 sec ramp down period to 0mA. Such method has been shown to provide effective blindness of the stimulation condition as both active and sham tES would lead to slight itching sensation that would disappear due scalp habitation. No further stimulation would be provided in the sham group during the daily session.

tDCS - placebo; tRNS - placebo

Eligibility Criteria

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

You may qualify if:

• Meet ADHD criteria according to the DSM-5
• Meet ADHD criteria according to "gold standard" AAP criteria = semi-structured interview, medical/neurological examination
• Score above the standard clinical cut off values for ADHD symptoms on ADHD-RS
• Drug naïve. -

You may not qualify if:

• Chronic neurological disease
• Epilepsy in subject or first degree relative
• Intellectual disability
• Any other chronic conditions
• Chronic use of medications
• Other primary psychiatric diagnosis (e.g., depression, anxiety, psychosis) -

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead

Study Sites (1)

Computerized Neurotherapy Lab, School of OT, Hebrew University

Jerusalem, Mount Scopus, 91240, Israel

Location

Related Publications (2)

• Berger I, Dakwar-Kawar O, Grossman ES, Nahum M, Cohen Kadosh R. Scaffolding the attention-deficit/hyperactivity disorder brain using transcranial direct current and random noise stimulation: A randomized controlled trial. Clin Neurophysiol. 2021 Mar;132(3):699-707. doi: 10.1016/j.clinph.2021.01.005. Epub 2021 Jan 27.

  PMID: 33561725 BACKGROUND

• Dakwar-Kawar O, Berger I, Barzilay S, Grossman ES, Cohen Kadosh R, Nahum M. Examining the Effect of Transcranial Electrical Stimulation and Cognitive Training on Processing Speed in Pediatric Attention Deficit Hyperactivity Disorder: A Pilot Study. Front Hum Neurosci. 2022 Jul 27;16:791478. doi: 10.3389/fnhum.2022.791478. eCollection 2022.

  PMID: 35966992 BACKGROUND

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Computerized Neurotherapy Lab

Model Details: 'tDCS-tRNS' arm: a randomized controlled crossover study. 'tRNS-Sham' arm: a randomized controlled trial

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 7, 2017
• Study Start: February 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: January 30, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)