Safety and research

Randomized controlled trial

RCT

Definition

A randomized controlled trial assigns participants by chance to intervention groups and compares outcomes between the concurrently followed groups.

Aliases and abbreviations

RCT · randomised controlled trial · randomized trial

Editorial record

Published: August 25, 2026 · Reviewed: August 25, 2026

Expanded definition

Randomized controlled trial

Random allocation aims to make prognostic factors similar on average between groups before the intervention begins, reducing confounding in the estimated comparison.

A control group may receive sham stimulation, another intervention, standard care, or no intervention. Blinding, allocation concealment, adherence, missing data, outcome measurement, and selective reporting still affect validity.

An RCT estimates an effect for the tested population, protocol, comparator, and outcomes. Its result should not automatically be transferred to another device, dose, setting, or intended use.

What the term does not establish

Keep the category boundary visible

  • It is not automatically unbiased simply because it is randomized.
  • It does not guarantee successful blinding or complete reporting.
  • One RCT is not the same as a complete body of evidence.

Why the distinction matters

Precision changes interpretation

Understanding what randomization does—and does not do—helps readers interpret trial results without treating the design label as a quality guarantee.

Related terms

Editorial scope

A definition is an entry point, not a product claim

This glossary entry supports general education. It does not diagnose, recommend treatment, or transfer findings from one VNS method, protocol, or device to another.

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