FindMyKOL
Clinical trialNCT01343563CompletedPhase 2Interventional

Trigeminal Nerve Stimulation for Depression: Dose Finding

SponsorUniversity of California, Los AngelesEnrollment20Depression
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) when added onto antidepressant medications. Our primary objective is the examination of two different "doses" of TNS, in terms of pulse frequency. To accomplish our specific aims, the investigators will test the following specific hypotheses: 1. Subjects will show greater improvement in ratings of mood and other symptoms of depression during the six-week of high frequency stimulation than during low frequency stimulation periods. 2. Subjects will show greater improvement after 12 weeks of high frequency stimulation than after six weeks of high frequency stimulation. 3. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS. 4. Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device. 5. Subjects will show significant differences in regional brain function at the end of the high frequency stimulation period compared with baseline, and significant differences between high and low frequency stimulation conditions.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Semel Institute for Neuroscience and Human Behavior at Ucla

    Los Angeles, California, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2011
Primary completion
31 Jan 2012
Completion
31 Jan 2012
Last update posted
6 Feb 2013
Registered enrollment
20
Registry id
NCT01343563

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.