External Trigeminal Nerve Stimulation for Epilepsy

NCT01159431 | Completed Phase 2 Results DMC

• 1 other identifier: TNS-TDP-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy; Seizure Disorders

Keywords

partial seizures; poorly controlled epilepsy; intractable epilepsy; treatment resistant epilepsy; Trigeminal Nerve; Trigeminal Nerve Stimulation

Outcome Measures

Primary Outcomes (3)

• 50% Responder Rate

  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.

  Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks

• Time to the 4th Seizure

  Number of Days to the 4th seizure

  treatment period (18-weeks)

• Change in Seizure Frequency

  Percent change in seizure frequency from baseline

  18 weeks

Secondary Outcomes (2)

• Response Ratio: Mean Percent Change in Seizures

  18 weeks

• Mood

  18-weeks

Study Arms (2)

Active

EXPERIMENTAL

Device: Trigeminal Nerve Stimulation

Control

OTHER

Device: Trigeminal Nerve Stimulation

Interventions

Trigeminal Nerve Stimulation DEVICE

External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit

Active; Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead
• Epilepsy Foundation: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (2)

USC Department of Neurology

Los Angeles, California, 90033, United States

Location

Olive View/UCLA Medical Center

Sylmar, California, 91342, United States

Location

Related Publications (2)

• DeGiorgio CM, Murray D, Markovic D, Whitehurst T. Trigeminal nerve stimulation for epilepsy: long-term feasibility and efficacy. Neurology. 2009 Mar 10;72(10):936-8. doi: 10.1212/01.wnl.0000344181.97126.b4. No abstract available.

  PMID: 19273830 BACKGROUND

• DeGiorgio CM, Soss J, Cook IA, Markovic D, Gornbein J, Murray D, Oviedo S, Gordon S, Corralle-Leyva G, Kealey CP, Heck CN. Randomized controlled trial of trigeminal nerve stimulation for drug-resistant epilepsy. Neurology. 2013 Feb 26;80(9):786-91. doi: 10.1212/WNL.0b013e318285c11a. Epub 2013 Jan 30.

  PMID: 23365066 RESULT

MeSH Terms

Conditions

Epilepsy; Seizures; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to sample size and high variability in seizure frequency, median change did not achieve significance. To constrain variability, the RRATIO was used to assess seizure frequency. The RRATIO demonstrated within groups differences, p=0.04 ANOVA.

Results Point of Contact

• Title: Dr. Christopher DeGiorgio
• Organization: UCLA

cmd@mednet.ucla.edu

310-206-3753

Study Officials

• Christopher M DeGiorgio, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Christi Heck, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 9, 2010
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 3, 2013
• Results First Posted: June 3, 2013

Record last verified: 2013-05

Locations

US (2)