TNS in children with ADHD
Overview
Are you aged between 8-18 years old?
And are you diagnosed with ADHD
The ATTENS project is looking for children with ADHD between 8-18 years old to try the first ever medical device as non-drug treatment for ADHD called TNS (trigeminal nerve stimulation).
The TNS device stimulates a nerve that goes into the brain and improves ADHD. TNS has minimal side effects and can be used with or without medication.
We would ask you to try the device while you sleep for four weeks and do some assessments before and after.
You may be able to get up to £450!
Are you interested in taking part in this study?
Planned end date
30 Apr 2025 10:42Conditions
ADHDInclusion Criteria
1) Children and adolescents, aged 8-18 years at study entry
2) ADHD diagnosis (DSM-5)
3) A score higher than 24 on the investigator-scored parent-rated ADHD-RS-5
4) scoring above clinical cut-off for ADHD on the Schedule for Affective Disorders and Schizophrenia, ADHD module (K-SADS) (Kaufman et al., 1996)
5) Scoring above clinical cut-off for ADHD on the short forms of the Conners Parent Rating Scales (CPRS)(Conners et al., 1998a, b).
6) IQ above 70 as assessed on the Wechsler Abbreviated Scale of Intelligence (WASI-II) (Wechsler, 1999)
7) Patients will be either medication-naïve, come off their stimulant medication for 2 weeks before the trial or be on stable medication for trial duration. Patients on stable stimulant medication will come off for 24-48 hours prior to pre, post and follow-up assessments. We will give priority to patients who are stimulant medication-naïve or not currently taking stimulant ADHD medication or other psychotropic medication or who are willing to come off their stimulant medication for 2 weeks before the trial and during the trial.
8) Comorbidity with conduct/oppositional defiant disorder will be allowed.
Exclusion Criteria
1) Comorbidity with any other major psychiatric disorder (except conduct/oppositional defiant disorder (see above), mild anxiety and depression (as assessed on the K-SADS)
2) Alcohol and substance abuse (as assessed on the K-SADS).
3) Neurological abnormalities, such as epilepsy.
4) Medication with atomoxetine or guanfacine.
5) Implanted cardiac or neurostimulation systems (contraindication to TNS)
6) Implanted metallic or electronic device in their head (contraindication to TNS)
7) Presence of body worn devices (e.g., insulin pumps and t-VNS) (contraindication to TNS)
Additional Exclusion Criteria for the 56 participants that will participate in the MRI study
8) Have any MR contra-indications (e.g., metal implants, pacemakers, claustrophobia etc.) which would render them unsuitable for the fMRI sub-study.
9) Be pregnant or breastfeeding if female.
