eTNS for DRE: External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy

Sponsor

NeuroSigma, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01978470

Collaborator

Olive View-UCLA Education & Research Institute (Other)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Seizure Disorder	Device: External Trigeminal Nerve Stimulation (eTNS)	N/A

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

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

External Trigeminal Nerve Stimulation for Epilepsy

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Trigeminal nerve stimulation	Device: External Trigeminal Nerve Stimulation (eTNS) External stimulation of the trigeminal nerve. Other Names: eTNS

Arm

Intervention/Treatment

Experimental: Active

Trigeminal nerve stimulation

Device: External Trigeminal Nerve Stimulation (eTNS)

External stimulation of the trigeminal nerve.

Other Names:

eTNS

Outcome Measures

Primary Outcome Measures

Safety of eTNS [Four weeks]
Number and percent of subjects with adverse events related to the device at four weeks.

Secondary Outcome Measures

Beck Depression Inventory [Four weeks]
Percentage change in Beck Depression Inventory score at four weeks compared to initial visit.
Quality of Life [Four weeks]
Absolute change in QOLIE-31 (Quality of Life in Epilepsy) Inventory scale and sub-scales at four weeks.
Systolic Blood Pressure and Heart Rate [Four weeks]
Absolute and percent change in systolic blood pressure and heart rate at four weeks compared to initial visit.
Skin Irritation [Four weeks]
Number and percentage of subjects with skin irritation > 1 on a standardized scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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