Trigeminal Nerve Stimulation for ADHD (TNS-PAE Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByJoseph O'Neill, PhD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Trial Summary

What is the purpose of this trial?This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE). TNS has been successful in treating pediatric ADHD generally and it is US Food and Drug Administration (FDA)-cleared for this condition. But this will be the first time it is tried for ADHD specifically associated with PAE. In TNS, a weak electric current is applied to the child's forehead overnight while sleeping to gently stimulate the brain. TNS is administered at home by the parent to the child. TNS is safe and well tolerated. Efficacy of TNS in ADHD is \~50%. The purpose of the present pilot study is to determine the feasibility of TNS for children with PAE and ADHD. Feasibility means safety (any serious side effects?), tolerability (do children comply with TNS? are they comfortable with it?), and a rough idea of efficacy (does TNS seem to work in most kids?) A secondary goal of the study is to get a more precise idea of brain mechanisms of TNS with magnetic resonance imaging (MRI). Families who participate will make three clinic visits: eligibility (4-5 hours), pre-TNS (2-3 hours including MRI), and post-TNS (2-3 hours including MRI). Children will receive TNS, applied by the parent, for 8 hours every night while sleeping for 4 weeks. Four weeks after treatment, families will take part in a telephone follow-up, to see whether any improvements made last.

Eligibility Criteria

This trial is for children aged 8-12 with ADHD due to prenatal alcohol exposure. They must be able to visit the clinic three times and have a parent who can apply the TNS device nightly for four weeks. Children should also be comfortable undergoing MRI scans.

Inclusion Criteria

I have been diagnosed with a condition related to alcohol exposure before birth.

I am between 8 and 12 years old.

Exclusion Criteria

I have a genetic condition linked to ADHD symptoms.

I have a serious illness that affects my brain function, like seizures.

I have been diagnosed with autism, a psychotic disorder, or a major mood disorder.

Participant Groups

The study tests Trigeminal Nerve Stimulation (TNS), where a weak electric current stimulates the brain overnight, on children with ADHD from prenatal alcohol exposure. It checks if TNS is safe, tolerated, and effective in these specific cases.

1Treatment groups

Experimental Treatment

Group I: Trigeminal Nerve StimulationExperimental Treatment1 Intervention

Each child will receive nightly trigeminal nerve stimulation, administered by the parent at bedtime, for 8 hrs while sleeping overnight, nightly for 4 weeks (28 days)