ISRCTN82129325Active, not recruitingPhase 2
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
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- King's College London
- Enrollment
- 150
Study Overview
Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38689273/ (added 14/05/2024)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •2. ADHD diagnosis (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [DSM-5])
- •3. A score higher than 24 on the investigator-scored parent-rated ADHD-RS-5
- •4. Scoring above the clinical cut-off for ADHD on the Schedule for Affective Disorders and Schizophrenia, ADHD module (K-SADS)
- •5. Scoring above the clinical cut-off for ADHD on the short forms of the Conners Parent Rating Scales (CPRS)
- •6. IQ above 70 as assessed on the Wechsler Abbreviated Scale of Intelligence (WASI-II)
- •7. Patients will be either medication-naïve, come off their stimulant medication for 2 weeks before the trial or be on stable medication for the trial duration. Patients on stable stimulant medication will come off for 24-48 hours prior to pre, post and follow-up assessments. The researchers 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
- •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)
- •10. Participants with dermatitis (could be sensitive to patches)
- •11. Traumatic Brain Injury (TBI) (potential confound)
- •Additional exclusion criteria for the 56 patients that will participate in the fMRI study
- •12. Under 10 years old
- •13. Have any MRI contra-indications (e.g., metal implants, pacemakers, braces, tattoos/piercings claustrophobia etc.) which would render them unsuitable for the fMRI sub-study
- •14. Be pregnant and/or breastfeeding if female
- •If patients are COVID positive, the participant’s involvement in the trial will be delayed. If any patient develops COVID during the trial, arrangements will be made as required for the individual case.
- •Previous 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)
Investigators
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