External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy (eTNS for DRE)

NeuroSigma

Status: Unknown

Conditions: Seizure Disorder

Treatments: Device: External Trigeminal Nerve Stimulation (eTNS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01978470

NS-076014-01

Details and patient eligibility

About

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

Full 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.......

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Active

Experimental group

Description:

Trigeminal nerve stimulation

Treatment:

Device: External Trigeminal Nerve Stimulation (eTNS)