Non-invasive Brain Stimulation for Pediatric ADHD

• Register: ClinicalTrials.gov
• Last refreshed on: 6 November 2023
• Main ID: NCT03104972
• Date of registration: 28/03/2017
• Prospective Registration: Yes
• Primary sponsor: Hebrew University of Jerusalem
• Public title: Non-invasive Brain Stimulation for Pediatric ADHD
• Scientific title: Non-invasive Brain Stimulation for Pediatric ADHD
• Date of first enrolment: February 1, 2018
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03104972
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Israel

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Meet ADHD criteria according to the DSM-5

2. Meet ADHD criteria according to "gold standard" AAP criteria = semi-structured
interview, medical/neurological examination

3. Score above the standard clinical cut off values for ADHD symptoms on ADHD-RS

4. Drug naïve. -

Exclusion Criteria:

1. Chronic neurological disease

2. Epilepsy in subject or first degree relative

3. Intellectual disability

4. Any other chronic conditions

5. Chronic use of medications

6. Other primary psychiatric diagnosis (e.g., depression, anxiety, psychosis) -



Age minimum: 6 Years
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

ADHD

Intervention(s)

Device: tDCS

Device: tRNS

Device: sham

Primary Outcome(s)

ADHD Rating Scale (ADHD-RS) parameters [Time Frame: 4 weeks]

Secondary Outcome(s)

MOXO-Continuous Performance Test standardized attention test [Time Frame: 4 weeks]

Wechsler Intelligence Scale for Children (WISC-IV) [Time Frame: 4 weeks]

Behavior Rating Inventory of Executive Function (BRIEF) [Time Frame: 4 weeks]

Secondary ID(s)

HMO-17-0180

Source(s) of Monetary Support

Please refer to primary and secondary sponsors