Seizure DisordereTNS for DRENCT01978470
External Trigeminal Nerve Stimulation for Drug Resistent Epilepsy
A study testing External Trigeminal Nerve Stimulation (eTNS) in people with Seizure Disorder, run by NeuroSigma, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS system. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seizure Disorder
- What is being tested?
- External Trigeminal Nerve Stimulation (eTNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: External Trigeminal Nerve Stimulation for Epilepsy
The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS system.
Read the 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.......
- Conditions
- Seizure Disorder
- Being tested
- External Trigeminal Nerve Stimulation (eTNS)
- Keywords
- epilepsy, drug resistent epilepsy, partial onset seizures, trigeminal nerve stimulation, neuromodulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Trigeminal Nerve Stimulation (eTNS)Device
Also called eTNS
External stimulation of the trigeminal nerve.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Trigeminal nerve stimulation Receives: Device: External Trigeminal Nerve Stimulation (eTNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of eTNS
Number and percent of subjects with adverse events related to the device at four weeks.
Measured: Four weeks
Secondary outcomes (4)
Beck Depression Inventory
Percentage change in Beck Depression Inventory score at four weeks compared to initial visit.
Measured: Four weeks
Quality of Life
Absolute change in QOLIE-31 (Quality of Life in Epilepsy) Inventory scale and sub-scales at four weeks.
Measured: Four weeks
Systolic Blood Pressure and Heart Rate
Absolute and percent change in systolic blood pressure and heart rate at four weeks compared to initial visit.
Measured: Four weeks
Skin Irritation
Number and percentage of subjects with skin irritation > 1 on a standardized scale.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seizure DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroSigma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Olive View-UCLA Education & Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978470
- Sponsor's protocol ID
- NS-076014-01
- Acronym
- eTNS for DRE
- Status last verified
- Apr 2016
- First submitted
- 1 Nov 2013
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Trigeminal Nerve Stimulation for Epilepsy
- ClinicalTrials.gov ID
- NCT01978470
- Acronym / sponsor ID
- eTNS for DRE / NS-076014-01
- Conditions
- Seizure Disorder
- Keywords
- epilepsy, drug resistent epilepsy, partial onset seizures, trigeminal nerve stimulation, neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NeuroSigma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Olive View-UCLA Education & Research Institute
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the tolerability and safety of the NeuroSigma eTNS system.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: External Trigeminal Nerve Stimulation (eTNS)Trigeminal nerve stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Trigeminal Nerve Stimulation (eTNS)Also: eTNSExternal stimulation of the trigeminal nerve. | Device | Active |
Primary outcome
Safety of eTNS
Time frame: Four weeks
Number and percent of subjects with adverse events related to the device at four weeks.
4 secondary outcomes
Beck Depression Inventory
Time frame: Four weeks
Quality of Life
Time frame: Four weeks
Systolic Blood Pressure and Heart Rate
Time frame: Four weeks
Skin Irritation
Time frame: Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Trigeminal Nerve Stimulation (eTNS) in people with Seizure Disorder, run by NeuroSigma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of eTNS (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.