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External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial
Aldo Alberto Conti1,2, Natali Bozhilova1, Irem Ece Eraydin3,4
1Department of Child & Adolescent Psychiatry, Institute of Psychiatry, Psychology & Neurosciences King's College London, London, UK.
External trigeminal nerve stimulation (TNS) is a safe treatment for pediatric attention-deficit/hyperactivity disorder (ADHD). However, this study found no significant clinical efficacy for TNS in treating ADHD symptoms in children and adolescents.
Area of Science:
- Neurology
- Pediatrics
- Clinical Trials
Background:
- External trigeminal nerve stimulation (TNS) gained FDA clearance for pediatric ADHD treatment in 2019.
- Previous pilot studies suggested TNS efficacy, necessitating further investigation.
Purpose of the Study:
- To confirm the efficacy and safety of TNS for pediatric ADHD.
- To evaluate both short-term and long-term (6-month) effects of TNS.
Main Methods:
- A multicenter, double-blind, randomized, sham-controlled, parallel-group phase 2b trial.
- 150 children and adolescents with ADHD received either real TNS or sham TNS nightly for 4 weeks.
Main Results:
- No significant difference in ADHD symptom improvement between real TNS and sham TNS groups.
- TNS was found to be safe, with no serious adverse events reported and similar side effects between groups.
Conclusions:
- External trigeminal nerve stimulation (TNS) is a safe intervention for pediatric ADHD.
- Current evidence does not support the clinical efficacy of TNS for treating ADHD in children and adolescents.
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