N/A
Completed N=18
12 Month Open Extension of TNS for ADHD.
Source: ClinicalTrials.gov NCT03888391 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: ADHD-IV Rating Scale (ADHD-RS) — 19.06; 16.56; 17.51; 15.55 score on a scale — p=.20
Summary
Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADHD-IV Rating Scale (ADHD-RS) |
19.06; 16.56; 17.51; 15.55; 15.97 | .20 |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) |
16; 2; 8; 0; 7; 0 | — |
| SECONDARY Height |
140.45; 143.09; 144.20; 147.27; 148.37 | <.0001 sig |
| SECONDARY Weight |
38.42; 38.76; 39.37; 39.96; 41.82 | .0004 sig |
| SECONDARY Systolic Blood Pressure |
109.06; 108.72; 110.06; 109.79; 102.18 | .60 |
| SECONDARY Diastolic Blood Pressure |
61.89; 64.33; 63.49; 64.40; 66.40 | .32 |
| SECONDARY Pulse |
81.56; 80.78; 76.83; 79.76; 77.25 | .27 |
Eligibility Criteria
Inclusion Criteria
- male and female children ages 8-13 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
- received active TNS therapy in a previous trial and demonstrated a CGI-I score <= 2.
- 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
- none
Data sourced from ClinicalTrials.gov (NCT03888391). 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.