Known true · enters 15 Jan 2028
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 15 Jan 2026 · owen-2057
Quote
“I’m looking forward to new data on large scale replication trials that should be published soon.”
Glossary entry for eTNS (Monarch eTNS device, FDA-cleared breakthrough device for refractory seizures and ADHD in youth). The author expects large-scale replication trial data to be published soon.
Intake
- EventA proposition written from a template on the asset, with a resolution criterion and a named public source, before the outcome is looked up. The same event resolves every person's items on it. Method ›
- Monarch eTNS large-scale replication trial results are published
- AreaOne of five topic classes: regulatory decisions, clinical trial outcomes, company and market outcomes, payer and policy, practice adoption. Every event has one area. Method ›
- Trial outcomes
- DeadlineThe date by which the event must happen for the item to be true. It comes only from the person's words through the anchor table. Method ›
- None stated · undated panelItems with no deadline in the person's words, scored on a uniform 24-month window from the statement date. Part of the headline panel since rules 1.1.0; also shown on its own. Method ›, 24-month window to 15 Jan 2028
- Probability
- 0.70 LexiconThe fixed five-bin table that turns a phrase into a probability. The strongest phrase in the claim sentence decides; coders never read tone. Method › · binOne of five lexicon steps: A 'will' 0.90, B 'probably' 0.70, C 'may' 0.50, D 'unlikely' 0.30, E 'never' 0.10. A stated number goes to the nearest bin for calibration only. Method › B · “should be published soon”
- Base rateThe probability a published external study gives an event of that class and stage, fixed at intake. Halved when the item window is shorter than the class median time to decision. Never learned from the ledger's own items. Method ›
- None in the table
- Tags
- retrospective
- Coder BCohen's kappa: agreement between two coders beyond chance, from -1 to 1. Reported for admit, event, deadline, bin and asserts from the second-coder match test. Method ›
- admittedA statement that passed intake: sincere, the person's own claim, forward-looking, inside the five areas, and not excluded by a reason code. Only admitted statements become items. Method › · event E-0057 · deadline none · bin B
Registry entry
Results of a randomized controlled replication trial of the Monarch eTNS device, larger than the trial behind its existing FDA clearance, are published, in any direction.
TRUE on the date of the first peer-reviewed publication (PubMed-indexed) or ClinicalTrials.gov results posting, dated after 2026-01-15, that reports primary-outcome results of a randomized controlled trial of the Monarch eTNS (external trigeminal nerve stimulation) device in one of the indications the forecaster names as cleared (ADHD in youth, or refractory seizures), designed to test the efficacy finding of the trial that supported the existing FDA clearance, and randomizing more participants than that pivotal trial. Any direction of result counts. Secondary analyses of earlier trials, open-label studies, and results already public on the statement date do not count. FALSE at the deadline when no such publication or posting is dated by then. Resolution source: PubMed (peer-reviewed publication), with ClinicalTrials.gov results as a secondary source.
Resolution source: PubMed (peer-reviewed publication); ClinicalTrials.gov results as a secondary source
Readings: 'Large scale replication trials' is read as randomized controlled trials that test the efficacy finding behind the current clearance and randomize more participants than that pivotal trial; the forecaster gives no number, so size is judged against the pivotal trial.; 'New data ... published' is read as a peer-reviewed publication or a results posting, in any direction.; 'Soon' sets no deadline.
How to read
Coder A
Resolution
- State
- Known trueAn item whose event has already happened but whose deadline has not passed. Shown as 'known true, enters on <deadline>'; pending in every metric until then. Method ›
- Effective deadlineAn item enters the score only when its deadline has passed and the outcome is true or false. A claim already known true still waits for its deadline. Method ›
- 15 Jan 2028
- Outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method ›
- occurred on 16 Jan 2026 · checked through 13 Sep 2026
- Resolver note
- Criterion: first PubMed-indexed publication or ClinicalTrials.gov posting dated after 2026-01-15 reporting primary results of an RCT of the Monarch eTNS in youth ADHD (or refractory seizures), designed to test the efficacy finding behind the FDA clearance and randomizing more participants than the pivotal trial (McGough 2019, NCT02155608, 62 randomized). Conti et al., Nature Medicine 32(2):582-590, published online 2026-01-16 (PubMed Epub 2026 Jan 16, PMID 41545587): multicentre double-blind sham-controlled phase 2b ATTENS trial (ISRCTN82129325) of the Monarch TNS System (NeuroSigma), 150 randomized (75/75), explicitly a confirmatory test of the pilot; primary outcome (parent ADHD-RS at 4 weeks) showed no differential effect (adjusted mean difference 0.83, P=0.622). Direction is irrelevant. No earlier registry results posting exists (UCLA NCT05374187, n=218, has none). Date = 2026-01-16.
- Evidence
- External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial (PMID 41545587; Nat Med 2026 Feb;32(2):582-590; Epub 2026 Jan 16) · 16 Jan 2026
- External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial · 16 Jan 2026
- External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial (full text, PMC12920111) · 16 Jan 2026
- Trigeminal Nerve Stimulation for ADHD (NCT02155608): pivotal double-blind sham-controlled trial, 62 randomized, results posted 2019-04-12 · 12 Apr 2019
- Efficacy of Trigeminal Nerve Stimulation for ADHD (NCT05374187): randomized, 218 enrolled, completed, no results posted
Adversarial recheck
upheld (date): Argued the date is wrong or the trial does not qualify. Three attacks failed. (1) Device: the PMC full text names the Monarch TNS System (NeuroSigma), the cleared device. (2) Size and design: ATTENS randomized 150 (75/75) against 62 in McGough 2019 (NCT02155608), the trial behind the April 2019 FDA clearance, and is described as a confirmatory replication, so it meets 'larger' and 'designed to test'. (3) Date: the window edge is tight, because the criterion needs a date after 2026-01-15 and the paper is Epub 2026-01-16. The Nature Medicine DOI carries a 2025 stem (s41591-025-04075-x), so I checked for an earlier online date; PubMed, PMC and Nature all give 16 January 2026, print Feb 2026;32(2):582-590. Nothing qualifying falls in the one-day gap, and UCLA NCT05374187 (n=218) has posted no results. The null primary result does not matter, because any direction counts.
How to read
Registry
Timeline
1 claim against 11 events in the field.
Trial outcomes