Trigeminal Nerve Stimulation (TNS) for Children with Attention Deficit/Hyperactivity Disorder and Fetal Alcohol...

Area of Science:

• Neuroscience
• Pediatrics
• Clinical Trials

Background:

• Attention deficit/hyperactivity disorder (ADHD) symptoms are prevalent and impairing in children with prenatal alcohol exposure (PAE).
• Current ADHD medications are often ineffective for this population, necessitating alternative treatments.
• External trigeminal nerve stimulation (TNS) is an FDA-cleared, non-invasive neuromodulatory intervention for ADHD.

Purpose of the Study:

• To conduct the first clinical trial of TNS in children with ADHD associated with PAE.
• To evaluate the safety, tolerability, and preliminary efficacy of TNS in this population.
• To explore the brain mechanisms underlying TNS effects using multimodal MRI.

Main Methods:

• An open-label pilot study involving 30 youth with ADHD and PAE.
• Four weeks of nightly TNS treatment.
• Assessment of clinical symptoms (ADHD Rating Scale, CGI-I), executive function, mood, and sleep.
• Multimodal MRI (sMRI, DTI, MRS, rs-fMRI) to examine brain changes.

Main Results:

• Preliminary data will assess feasibility, safety, and tolerability of TNS.
• Efficacy outcomes will measure changes in ADHD symptoms and related cognitive/mood effects.
• MRI data will identify TNS-related brain changes and potential predictors of treatment response.

Conclusions:

• This study will determine the feasibility of TNS for children with ADHD and PAE.
• It will provide initial evidence on TNS efficacy for improving clinical and cognitive symptoms.
• The study aims to understand the neural underpinnings of TNS treatment in this vulnerable population.