Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06847165
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Trigeminal Nerve Stimulation (TNS) — DEVICE
    In TNS, a weak electric current is applied to the child's forehead overnight while sleeping to gently stimulate the brain. TNS treatment is typically administered at home at bedtime by the parent to the child. The TNS device is small (size of a cell phone) and easy to use. Two thin wires go from the device to a pair of small electrodes that tape onto the forehead like a band-aid. The parent presses three keys on the device and it is ready to go.

Study Details

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.

Key Dates

Start date
Apr 26, 2025
Status verified
Jun 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trigeminal Nerve Stimulation
    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)

Primary Outcome Measure

Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale Total Score [ Time Frame: administered at baseline and up to 1 week after completing 4 weeks of trigeminal nerve stimulation (TNS) treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Los Angeles Semel Institute Division of Child & Adolescent PsychiatryLos AngelesCalifornia90024
Lindy B Comstock, PhD
[email protected]
Joseph O'Neill, PhD
[email protected]
(310) 825-5709
Joseph O'Neill, PhD (PRINCIPAL_INVESTIGATOR)
Mary J O'Connor, PhD (SUB_INVESTIGATOR)
Benjamin N Schneider, MD (SUB_INVESTIGATOR)
Jeffry R Alger, PhD (SUB_INVESTIGATOR)
Shantanu Joshi, PhD (SUB_INVESTIGATOR)
Lindy B Comstock, PhD (SUB_INVESTIGATOR)
Andrew F Leuchter, MD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California Los Angeles Semel Institute Division of Child & Adolescent Psychiatry· Los Angeles, CA

Related Studies