External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy

Seizure Disorder Clinical Trial

— eTNS for DRE  

Official title:

External Trigeminal Nerve Stimulation for Epilepsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01978470
• Other study ID #: NS-076014-01
• Status: Active, not recruiting
• Phase: N/A
• First received: November 1, 2013
• Last updated: April 11, 2016
• Start date: June 2012
• Est. completion date: August 2016

Study information

• Verified date: April 2016
• Source: NeuroSigma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.......

Other known NCT identifiers

• NCT01607567

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Epilepsy
• Seizure Disorder

Intervention

Device:
• External Trigeminal Nerve Stimulation (eTNS)
External stimulation of the trigeminal nerve.

Locations

Country	Name	City	State
United States	Olive View/UCLA Medical Center	Sylmar	California

Sponsors (2)

Lead Sponsor	Collaborator
NeuroSigma, Inc.	Olive View-UCLA Education & Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of eTNS	Number and percent of subjects with adverse events related to the device at four weeks.	Four weeks	Yes
Secondary	Beck Depression Inventory	Percentage change in Beck Depression Inventory score at four weeks compared to initial visit.	Four weeks	No
Secondary	Quality of Life	Absolute change in QOLIE-31 (Quality of Life in Epilepsy) Inventory scale and sub-scales at four weeks.	Four weeks	No
Secondary	Systolic Blood Pressure and Heart Rate	Absolute and percent change in systolic blood pressure and heart rate at four weeks compared to initial visit.	Four weeks	Yes
Secondary	Skin Irritation	Number and percentage of subjects with skin irritation > 1 on a standardized scale.	Four weeks	Yes