tRNS Treatment for ADHD Symptoms

INCLUSION CRITERIA:

1. Age between 7-12 years old at the time of enrollment

2. Estimated Full Scale IQ ≥ 85 based on WASI-II (Two-subtests Form) NOTE: Results ofan equivalent and validated IQ test that were performed in the previous 12 monthsfrom the date of enrollment are acceptable. The Investigator must ensure that nosignificant head injuries, particularly significant head trauma, occurred in thisperiod from the previous test to the enrollment.

3. Score above the standard clinical cut-off score for ADHD symptoms on the ADHD DSM-5scales

4. Meet criteria for ADHD according to DSM-5, using the "gold standard" procedure asdescribed by the American Academy of Pediatrics, which includes a semi-structuredinterview of the subject and parent(s)/legal guardian(s)

5. Moderate to severe ADHD as defined as having a minimum score of 12 on either theinattention subscale or the and hyperactivity-impulsivity subscale of the baselineADHD Rating Scale (ADHD-RS), and a Clinical Global Impression-Severity (CGI-S) scoreat baseline of greater than 4

6. Parent(s)/legal guardian(s) fluent in English, able to complete ADHD-RS scale andattend all study visits

7. Has not taken any medication with central nervous system effects, includingprescription medications for ADHD, within 7 days of enrollment, as determined by theinvestigator based on the subject's medical history from the parent(s)/legalguardian(s) and, as applicable, medical and pharmacy records

EXCLUSION CRITERIA:

1. Has a history of any medical or psychiatric disorder, disease, condition, injury,symptoms or circumstance that, in the opinion of the principal investigator, may: (1) reduce the subject's ability to fulfill the study requirements as per protocol;or (2) adversely impact the integrity of the data or the validity of the studyresults

2. Primary DSM-5 axis-1 disorder other than ADHD, which consists of one or more ofsevere ODD, bipolar psychosis, major depressive disorder, severe oppositionaldefiant disorder that would pose adherence challenges by the investigator

3. Substance abuse, that, in the opinion of the investigator, may: (1) reduce theparticipant's ability to fulfill the study requirements as per protocol; or (2)adversely impact the integrity of the data or the validity of the study results

4. Impaired functioning to a degree that requires immediate initiation of ADHDmedication in the opinion of the Investigator

5. Known hypersensitivity to Polyamide or Elastomer

6. Any suicide risk as assessed with the Columbia-Suicide Severity Rating Scale (Pediatric (≤11 years) Quick Screen)

7. If female, began menstruation, based on a self- or parent(s)/legalguardian(s)-report

8. Any other condition, which would make the participant unsuitable to participate inthis study as determined by the Investigator

9. Inability to provide informed consent and assent (participant and parent(s)/legalguardian(s))