NCT01978470

Brief Summary

The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS system.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

4 years

First QC Date

November 1, 2013

Last Update Submit

April 11, 2016

Conditions

Seizure Disorder

Keywords

epilepsydrug resistent epilepsypartial onset seizurestrigeminal nerve stimulationneuromodulation

Outcome Measures

Primary Outcomes (1)

  • Safety of eTNS

    Number and percent of subjects with adverse events related to the device at four weeks.

    Four weeks

Secondary Outcomes (4)

  • Beck Depression Inventory

    Four weeks

  • Quality of Life

    Four weeks

  • Systolic Blood Pressure and Heart Rate

    Four weeks

  • Skin Irritation

    Four weeks

Study Arms (1)

Active

EXPERIMENTAL

Trigeminal nerve stimulation

Device: External Trigeminal Nerve Stimulation (eTNS)

Interventions

External Trigeminal Nerve Stimulation (eTNS)DEVICE

External stimulation of the trigeminal nerve.

Also known as: eTNS
Active

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Partial onset seizures (complex partial or secondary generalized tonic-clonic)
  • At least one seizure every three months
  • No serious or progressive medical or psychiatric illness
  • At least one complex partial or generalized tonic-clonic seizure in the last three months
  • MRI or EEG consistent with localization-related or partial epilepsy
  • Exposure to at least two anti-epileptic drugs at adequate doses
  • Concurrent use of at least one anti-epileptic drug at adequate doses
  • No change in anti-epileptic drug dose for at least 30 days prior to study enrollment

You may not qualify if:

  • Vagus nerve stimulation (VNS)
  • History of non-epileptic seizures
  • Inability to maintain accurate seizure calendars (self or caregiver)
  • Frequent use of benzodiazepines for seizure clusters defined as greater that four times per month
  • History of facial pain or trigeminal neuralgia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olive View/UCLA Medical Center

Sylmar, California, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 7, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

US(1)