A multi-centre, double-blind, randomized, parallel-group, Phase IIb study to compare the efficacy of real versus sham external trigeminal nerve stimulation on symptoms in youth with attention deficit hyperactivity disorder

King's College London0 sites150 target enrollmentAugust 2, 2021

Overview

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38689273/ (added 14/05/2024)

Registry

who.int

Start Date

August 2, 2021

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Current inclusion criteria as of 12/08/2022:
•1\. Children and adolescents, aged 8\-18 years at study entry
•2\. ADHD diagnosis (DSM\-5; based on the K\-SADS)
•3\. A score higher than 24 on the investigator\-scored parent\-rated ADHD\-RS (DSM\-5\) (to include participants who still have relatively high symptoms)
•4\. Scoring above the clinical cut\-off for ADHD (5 or above) on the combined summary score of the child and parent ratings Kiddie Schedule for Affective Disorders and Schizophrenia, for School\-age Children\- present and lifetime version, ADHD module (K\-SADS) (Kaufman et al., 1996\)
•5\. Both parent and child need to speak English (defined as sufficient to complete study assessments)
•6\. IQ above 70 as assessed on the Wechsler Abbreviated Scale of Intelligence (WASI\-II) (Wechsler, 1999\) (to exclude participants with a learning disability)
•7\. Patients should be either medication\-naïve OR willing to come off their stimulant medication for one week before the trial OR willing to be on stable medication for the duration of the trial.
•Previous inclusion criteria:
•1\. Children and adolescents, aged 8\-18 years at study entry

•Current exclusion criteria as of 12/08/2022:
•1\. Comorbidity with any other major psychiatric disorder (except conduct/oppositional defiant disorder, mild anxiety and depression\- as assessed on the K\-SADS, as these are commonly associated with ADHD)
•2\. Alcohol and/ or substance abuse (as assessed on the K\-SADS) (potential confound)
•3\. Neurological abnormalities, such as epilepsy (potential confound)
•4\. Current medication with atomoxetine or guanfacine or in the past two weeks (as these have an effect on the arousal system to be improved with eTNS)
•5\. Participants who usually take drug holidays on weekends or holidays will not be able to participate in the study unless they are willing to take their stimulant medication in a stable way throughout the study or not at all throughout the study and 1 week before the study (Participants will be either on medication or off medication to decrease heterogeneity).
•6\. Implanted cardiac or neurostimulation systems (contraindication to eTNS)
•7\. Implanted metallic or electronic device in their head (contraindication to eTNS)
•8\. Presence of body\-worn devices (e.g., insulin pumps and t\-VNS) (contraindication to eTNS)
•9\. Currently receiving any non\-medical treatment (e.g., psychotherapy, counselling, parent\-training, cognitive rehabilitation, EEG neurofeedback) (potential confound)