Efficacy of Trigeminal Nerve Stimulation for ADHD (NCT05374187) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Trigeminal Nerve Stimulation for ADHD
United States218 participantsStarted 2022-09-01
Plain-language summary
This study is a large multisite randomized clinical trial to asses the efficacy of external trigeminal nerve stimulation (TNS), a novel, minimal risk, non-invasive neuromodulation treatment, for ADHD in children ages 7-12 years old (N=180).
Study hypotheses address potential differences in ADHD symptoms over 4 weeks treatment with active vs. sham TNS in an expanded multi-site investigation; whether resting state fronto-parietal connectivity mediates TNS impact on ADHD symptoms; if changes in fronto-parietal activation, as measured by electroencephalography (EEG), predict TNS-related treatment outcomes; and whether a baseline cognitive profile similarly predicts response to TNS therapy.
Who can participate
Age range7 Years – 12 Years
SexALL
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Inclusion criteria
✓. male and female children ages 7 to 12 years with DSM-5 ADHD, any current presentation, as determined by diagnostic interview, Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), and clinical interview;
✓. total score \>= 24 on baseline ADHD-RS;
✓. CGI-S score at baseline \>= 4;
✓. no current medication with CNS effects (Participants previously on psychostimulant medication will be required to be not optimally treated and off medication for one week or 5 half-lives for all other medications); stable use of supplements will be permitted;
✓. parents able and willing to monitor proper use of the stimulation device and complete all required rating scales;
✓. estimated Full Scale IQ \>= 80 based on WASI subtests;
✓. parent and participant able to complete rating scales and other measures in English;