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NCT01159431 · ClinicalTrials.gov registry record · Phase 2

External Trigeminal Nerve Stimulation for Epilepsy

A Phase 2 study, sponsored by Olive View-UCLA Education & Research Institute.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT01159431: Completed Phase 2 study, sponsored by Olive View-UCLA Education & Research Institute.

NCT01159431 is a Phase 2 study that has completed, run by Olive View-UCLA Education & Research Institute. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01159431, a Phase 2 study, has completed, sponsored by Olive View-UCLA Education & Research Institute.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS). TNS involves external electrical stimulation of sensory nerve located above the eyes and over the forehead. The purpose of this study is to determine if TNS is safe and effective using a rigorous randomized active-control clinical trial design in 50 people with epilepsy.

Primary Outcome

Change in responder rate, at end of study (18 weeks) Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage.

Interventions

  • DEVICE Trigeminal Nerve Stimulation

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2008-01
Est. Completion 2011-06
Phase Phase 2

What the finished NCT01159431 record still lists

NCT01159431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 1 intervention - of which Trigeminal Nerve Stimulation is the first listed.

NCT01159431 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01159431 about?

NCT01159431 is a clinical study titled "External Trigeminal Nerve Stimulation for Epilepsy". This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS). TNS involves external electrical stimulation of sensory nerve located above the eyes and over the forehead. The purpose of this study is to determine if TNS is safe and effective using a rigorous randomized...

What is the current status of trial NCT01159431?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-01. Estimated completion is 2011-06.

What interventions are being tested in trial NCT01159431?

The interventions under investigation include: Trigeminal Nerve Stimulation (DEVICE).

Who is sponsoring clinical trial NCT01159431?

This trial is sponsored by Olive View-UCLA Education & Research Institute, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01159431's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01159431, the US trial registry maintained by the National Library of Medicine. NCT01159431 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.