N/A
Completed N=22
Four-week Open-trial Extension TNS for ADHD
Source: ClinicalTrials.gov NCT03870737 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: ADHD-IV Rating Scale (ADHD-RS) — 28.50; 20.91; 18.63 score on a scale — p=<.0001
Summary
The purpose of this study will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opportunity to receive 4-weeks active TNS treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADHD-IV Rating Scale (ADHD-RS) |
28.50; 20.91; 18.63 | <.0001 sig |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) |
11; 11; 12; 8 | — |
| SECONDARY Height |
140.19; 140.49; 140.92 | .02 sig |
| SECONDARY Weight |
34.19; 34.61; 34.91 | .0005 sig |
| SECONDARY Systolic Blood Pressure |
107.27; 109.83; 107.78 | .67 |
| SECONDARY Diastolic Blood Pressure |
59.41; 58.36; 60.51 | .76 |
| SECONDARY Pulse |
75.81; 77.04; 76.11 | .80 |
Eligibility Criteria
Inclusion Criteria
- male and female children ages 8-12 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
- participated in a previous randomized, double-blind, sham-controlled trial of TNS for ADHD, and randomized to the sham condition.
- parents able and willing to monitor proper use of the TNS device and complete all required rating scales
- parent and participants able to compete study rating scales and other measures in English
Exclusion Criteria
- currently requiring any medication with CNS effects
Data sourced from ClinicalTrials.gov (NCT03870737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.