Randomized Double Blind Study of External Trigeminal Nerve Stimulation for Intractable Epilepsy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- 50% Responder Rate
Study Overview
Brief Summary
This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS). TNS involves external electrical stimulation of sensory nerve located above the eyes and over the forehead. The purpose of this study is to determine if TNS is safe and effective using a rigorous randomized active-control clinical trial design in 50 people with epilepsy.
Detailed Description
Poorly controlled epilepsy is a disabling condition, affecting over one million Americans. Neurostimulation is a promising alternative for patients who have failed medical therapy, and who are not resective surgical candidates.
Trigeminal Nerve Stimulation (TNS) is a novel form of neurostimulation, and has a strong antiepileptic effect in an animal model of seizures. Preliminary data in humans indicates TNS is well tolerated and may be effective in people with intractable epilepsy.
TNS is an alternative mode of neurostimulation, because the Trigeminal Nerve can be stimulated in minimally-invasive fashion.
This is a randomized double blind study of Trigeminal Nerve Stimulation, which compares high stimulation to an active control. Subjects with poorly controlled partial onset seizures who meet all inclusion and exclusion criteria, enter a 6-week baseline period, and then are randomized in double-blind fashion to high or low intensity stimulation for 18 weeks. 50 subjects are to be enrolled at two sites.
Study outcomes are the following:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages 18 - 70;
- •No serious or progressive medical illness;
- •A history of intractable partial seizures;
- •At least two complex partial or tonic clonic generalized seizures per month in the last two consecutive months;
- •MRI or EEG consistent with localization-related or partial epilepsy;
- •Exposure to at least two antiepileptic drugs at adequate doses;
- •Concurrent use of at least one antiepileptic drug at adequate doses;
- •No change in antiepileptic dose for at least 30 days before study enrollment
Exclusion Criteria
- •History of non-epileptic seizures;
- •Inability to maintain accurate seizure calendars (self or caregiver);
- •Frequent use of benzodiazepines for clusters defined as greater than four times a month;
- •History of facial pain or trigeminal neuralgia;
- •Concurrent vagus nerve stimulation;
- •Pregnancy
Outcomes
Primary Outcomes
50% Responder Rate
Time Frame: Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks
Change in responder rate, at end of study (18 weeks) Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage.
Time to the 4th Seizure
Time Frame: treatment period (18-weeks)
Number of Days to the 4th seizure
Change in Seizure Frequency
Time Frame: 18 weeks
Percent change in seizure frequency from baseline
Secondary Outcomes
- Response Ratio: Mean Percent Change in Seizures(18 weeks)
- Mood(18-weeks)
Investigators
Christopher DeGiorgio
PI
Olive View-UCLA Education & Research Institute