OPEN RESEARCH STUDY
ATTENS/TNS in children with ADHD
Category:
Children and Adolescent Mental Health
Open to:
Children
Overview
The ATTENS project is looking for children with ADHD between ages 8 and 18 to try the first ever medical device called the TNS (trigeminal nerve stimulation) as non-drug treatment to help with ADHD. The device is worn while you are asleep
Inclusion criteria
Children and adolescents, aged 8-18 years at study entry
ADHD diagnosis (DSM-5; based on the K-SADS)
A score higher than 24 on the investigator-scored parent-rated ADHD-RS (DSM-5) (to include participants who still have relatively high symptoms)
Scoring above 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[1]present and lifetime version, ADHD module (K-SADS) (Kaufman et al., 1996)
Both parent and child need to speak English (defined as sufficient to complete study assessments)
IQ above 70 as assessed on the Wechsler Abbreviated Scale of Intelligence (WASI-II) (Wechsler, 1999) (to exclude participants with learning disability)
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.
Exclusion criteria
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)
Alcohol and/ or substance abuse
Neurological abnormalities, such as epilepsy
Current medication with atomoxetine or guanfacine or in the past two weeks
Implanted metallic or electronic device in their head
Presence of body worn devices (e.g., insulin pumps and tVNS) Currently receiving any non-medical treatment (e.g., psychotherapy, counselling, parent-training, cognitive rehabilitation, EEG neurofeedback)
Participants with dermatitis
Traumatic Brain Injury (TBI)
What is involved?
If you choose to take part you will be interviewed and asked some questions about your child’s symptoms and behaviour and also provide some background information and medical history. T This can be done either virtually or face to face and be split into more than one session.
Agree to take your child to the research centre at either London or Southampton for at least four visits.
You may be get paid up to £450
Once you have been given the eTNS device, we will ask you to fill in some questionnaires about your child every week as well as a daily sleep diary (to record for how long your child wore the device every day) for four weeks.
Interested in taking part?
Email the team to find out more: research@solent.nhs.uk