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Clinical Trials/NCT01978470
NCT01978470UnknownNot Applicable

External Trigeminal Nerve Stimulation for Epilepsy

NeuroSigma, Inc.1 site in 1 country20 target enrollmentStarted: June 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
Safety of eTNS
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

This study evaluates the safety and tolerability of the NeuroSigma eTNS system for the treatment of drug resistent partial seizures.

Up to 20 subjects, ages 18 - 75, with partial epilepsy will be enrolled in an acute 4-week tolerability study at Olive View/UCLA Medical Center .......

Enrolled subjects will be asked to maintain an accurate seizure calendar, and will be seen at the initial visit, then at two and four weeks.......

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Safety of eTNS

Time Frame: Four weeks

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

Secondary Outcomes

  • Beck Depression Inventory(Four weeks)
  • Quality of Life(Four weeks)
  • Systolic Blood Pressure and Heart Rate(Four weeks)
  • Skin Irritation(Four weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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