Trigeminal Nerve Stimulation for ADHD
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a
      potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD).

      Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment
      on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles,
      other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect
      profiles.
    

Detailed description: 
      This three-year developmental study is a double-blind randomized trial of active vs. inactive
      sham eTNS for ADHD, with four weeks acute treatment followed by an additional one week of
      clinical observation and testing after treatment cessation.

      The study will enroll 85-90 participants aged 8-12 years to achieve a completion target of
      N=36 for each study condition (total final N = 72). Participants will meet Diagnostic and
      Statistical Manual-5 (DSM-5) criteria for ADHD, any current presentation, as established by
      the Behavior Disorders Module of the Kiddie Schedule for Affective Disorders and
      Schizophrenia (KSADS-PL) and clinical interview.

      Other screening procedures include measures of ADHD symptom severity, other behavioral
      ratings, and cognitive assessments. Once inclusion/exclusion criteria have been reviewed and
      verified, participants in Phase 1A will have a pre-treatment visit to establish behavioral
      and cognitive baseline ratings and to obtain an EEG. Participants and parents will be
      instructed in the use of eTNS, and participants will begin use of the eTNS as directed during
      sleep each night. Participants will be randomized 1:1 to active or inactive sham eTNS.
      Participants, families, and most of the study team will remain blind to treatment assignment.
      Participants will have weekly assessments over the five-week study to assess behavioral,
      cognitive, and brain activation change and to monitor safety, tolerability, and compliance.
      Weekly ratings will be obtained from a parent, teacher, and clinician investigator. EEG will
      occur at baseline, end of treatment (week 4).

      In Phase 1B, all participants remain blinded for one week after cessation of the intervention
      and return for a final visit to assess residual effects of eTNS therapy vs. sham.
    

Intervention name(s): Active eTNS; Sham eTNS
Intervention type(s): Device; Device
Intervention description(s): Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period.; Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period.
Other intervention name(s): Trigeminal Nerve Stimulation; Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; neuromodulation; trigeminal nerve stimulation; cognition