External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy

NCT ID: NCT01978470

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-08-31

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.......

Conditions

Seizure Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Active

Trigeminal nerve stimulation

Group Type: EXPERIMENTAL

External Trigeminal Nerve Stimulation (eTNS)

Intervention Type: DEVICE

External stimulation of the trigeminal nerve.

Interventions

External Trigeminal Nerve Stimulation (eTNS)

External stimulation of the trigeminal nerve.

Intervention Type: DEVICE

Other Intervention Names

eTNS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olive View-UCLA Education & Research Institute

OTHER

Sponsor Role: collaborator

NeuroSigma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Olive View/UCLA Medical Center

Sylmar, California, United States

Countries

United States

Other Identifiers

NS-076014-01

Identifier Type: -

Identifier Source: org_study_id

NCT01607567

Identifier Type: -

Identifier Source: nct_alias