EpilepsyGTENNCT02516228
Transcranial Electrical Neuromodulation for Suppressing Epileptiform Discharges
A study testing GTEN 100 in people with Epilepsy, run by Electrical Geodesics, Inc. at 1 site in United States.
Trial summary
This study examines the safety and feasibility of suppressing epileptic discharges through inducing long term depression of the epileptic focus with transcranial electrical neuromodulation. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- GTEN 100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14 to 60.
- Partial onset seizures (simple or complex) with failure of adequate seizure control after prior use of at least 2 anti-seizure drugs at effective doses.
- Only one clearly identified and localizable extratemporal focus of epileptiform discharges, as defined the discharges (typically epileptiform spikes) and as identified by dEEG assessment through one or more routine clinical dEEG evaluations.
- Two or more partial seizures, with or without secondary generalization, in the last month, but less than 10 seizures per day.
- Anti-seizure drug regimen has remained unchanged for the month before study entry, and there is reasonable likelihood of stability for the duration of the study, with the exception of allowing short-term rescue medications, such as lorazepam.
- A history of epilepsy for at least 2 years.
Who cannot join
- Patient is pregnant or becomes pregnant
- A history or condition of progressive brain disorders, unstable systemic diseases, symptomatic cerebrovascular disease, cardiac disease, or alcohol/substance abuse.Special conditions, for example, non-malignant brain tumors and vascular malformations, can be considered for entry on a case-by-case basis.
- A history or condition of status epilepticus or psychogenic seizures (seizures not confirmed by EEG).
- Presence of a cardiac pacemaker, vagus nerve stimulator, or metal implants in the body (other than the teeth) including neurostimulators, cochlear implants, and implanted medication pumps (screened using the LCNI Safety Screening Questionaire).
- Previous surgery involving opening the skull.
- Allergy to or condition contraindicating lidocaine.
Show all 11Show fewer
- Unable to express presence of pain or discomfort.
- Allergy to silver
- Participating in other competing clinical trials
- Unable to speak English
- Unable to knowingly give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center - University of Washington
Seattle, Washington, 98104
About this study
Official title: Geodesic Transcranial Electrical Neuromodulation(GTEN100) Device
This study examines the safety and feasibility of suppressing epileptic discharges through inducing long term depression of the epileptic focus with transcranial electrical neuromodulation.
Read the detailed description
One third of patients with epilepsy continue to have seizures despite receiving antiepileptic medication. The application of low frequency repetitive transcranial magnetic stimulation (rTMS) has shown promise for decreasing the frequency of epileptic seizures in drug refractory patients. The mechanism of action appears to be induction of long term depression (LTD) in the targeted cortex by the low frequency (0.5 Hz or 1 every 2 sec) pulses. Unfortunately, the electrical stimulation induced by available TMS coils is limited to the most superficial (gyral) regions of cortex, whereas epileptic foci may occur in sulci, and in deep as well as superficial cortex. The investigators have developed the ability to target currents to specific regions of cortex by aligning source and sink electrodes with flexible subsets of a 256 channel geodesic electrode array. A first step is accurate localization of the likely epileptic focus with 256 channel EEG. Detailed computational models of the electrical properties of head tissues allow optimization studies to select the best pattern of source-sink electrodes for that individual's head tissues and epileptic focus. The goal of the safety and feasibility trial is to test whether one week (5 days) of GTEN treatment can achieve a similar depression of the target cortical region as low frequency rTMS, with the decrease in excitability measured by suppression of epileptic spikes. This safety and feasibility trial has received an Investigational Device Exemption from the FDA for treating 20 patients with focal neocortical epilepsy. Pulsed (emulating rTMS) current sequences will be evaluated. The GTEN system implements a number of advanced technologies that provide improved targeting compared to conventional rTMS or tDCS, including electronics for both pulsed and sustained delivery of current with 256 electrodes; double fault safety circuits; computational modeling of the electromagnetic properties of the patient's head tissue for GTEN targeting with medical grade software; a lidocaine electrolyte that minimizes pain of the pulsed or sustained current with up to 200 µA per electrode (2 mA total); and online safety monitoring for adverse EEG changes with the 256 dEEG array. Based on FDA feedback to date, success with these trials will allow us to progress to a pivotal clinical efficacy trial (with separate funding) to support a de novo 510k approval for GTEN treatment for the temporary suppression of seizures in patients with drug-resistant epilepsy.
- Conditions
- Epilepsy
- Being tested
- GTEN 100
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTEN 100Device
Also called GTEN
Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day.
During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days.
| Study group | Role | What they receive |
|---|---|---|
| GTEN 100 | Experimental | All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only. Receives: Device: GTEN 100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Spikes Per Hour
The main efficacy endpoint will be the change from baseline in number of spikes per hour (spike rate), as assessed with routine dEEG sessions, at each visit and after each treatment sessions.
Measured: Baseline and following the 5 day treatment session
Secondary outcomes (4)
Change in Seizures
Weekly change in the number of seizures, assessed by the seizure diary in comparison to the mean weekly seizure frequency for the baseline evaluation period;
Measured: Baseline measurement and the Nine Month visit
Change in Cognitive Function Test Score
Change of cognitive function testing score beyond the practice effect (estimated from norms) ;
Measured: Nine months
Change in Quality of Life Rating
Change from baseline in quality of life rating
Measured: Nine months
Duration of Spike Count Suppression
- With assessments of spike rates after treatment session and at visits at weeks 2, 4, 8, 16, and 24, the duration of any suppression in spike rate can be explored. All spike rates (baseline, treatment, and follow-up) will also be classified in relation to waking or sleep stage (N1, N2, N3).
Measured: Measured at baseline. treatment and at the 9 month followup visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startAug 2016
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Business decision to discontinue development of this investigational device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Electrical Geodesics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harborview Injury Prevention and Research Center
- Responsible party
- Sponsor
- Investigators
- Don M Tucker, Ph.D, Principal investigator, C.E.O/, Chief Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516228
- Sponsor's protocol ID
- EGI-001
- Acronym
- GTEN
- Status last verified
- Oct 2019
- First submitted
- 23 Jul 2015
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geodesic Transcranial Electrical Neuromodulation(GTEN100) Device
- ClinicalTrials.gov ID
- NCT02516228
- Acronym / sponsor ID
- GTEN / EGI-001
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to discontinue development of this investigational device
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Electrical Geodesics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Harborview Injury Prevention and Research Center
- Study start
- Aug 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Posted 22 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the safety and feasibility of suppressing epileptic discharges through inducing long term depression of the epileptic focus with transcranial electrical neuromodulation.
Detailed description
One third of patients with epilepsy continue to have seizures despite receiving antiepileptic medication. The application of low frequency repetitive transcranial magnetic stimulation (rTMS) has shown promise for decreasing the frequency of epileptic seizures in drug refractory patients. The mechanism of action appears to be induction of long term depression (LTD) in the targeted cortex by the low frequency (0.5 Hz or 1 every 2 sec) pulses. Unfortunately, the electrical stimulation induced by available TMS coils is limited to the most superficial (gyral) regions of cortex, whereas epileptic foci may occur in sulci, and in deep as well as superficial cortex. The investigators have developed the ability to target currents to specific regions of cortex by aligning source and sink electrodes with flexible subsets of a 256 channel geodesic electrode array. A first step is accurate localization of the likely epileptic focus with 256 channel EEG. Detailed computational models of the electrical properties of head tissues allow optimization studies to select the best pattern of source-sink electrodes for that individual's head tissues and epileptic focus. The goal of the safety and feasibility trial is to test whether one week (5 days) of GTEN treatment can achieve a similar depression of the target cortical region as low frequency rTMS, with the decrease in excitability measured by suppression of epileptic spikes. This safety and feasibility trial has received an Investigational Device Exemption from the FDA for treating 20 patients with focal neocortical epilepsy. Pulsed (emulating rTMS) current sequences will be evaluated. The GTEN system implements a number of advanced technologies that provide improved targeting compared to conventional rTMS or tDCS, including electronics for both pulsed and sustained delivery of current with 256 electrodes; double fault safety circuits; computational modeling of the electromagnetic properties of the patient's head tissue for GTEN targeting with medical grade software; a lidocaine electrolyte that minimizes pain of the pulsed or sustained current with up to 200 µA per electrode (2 mA total); and online safety monitoring for adverse EEG changes with the 256 dEEG array. Based on FDA feedback to date, success with these trials will allow us to progress to a pivotal clinical efficacy trial (with separate funding) to support a de novo 510k approval for GTEN treatment for the temporary suppression of seizures in patients with drug-resistant epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GTEN 100 | Experimental | Device: GTEN 100All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 14 to 60.
- Partial onset seizures (simple or complex) with failure of adequate seizure control after prior use of at least 2 anti-seizure drugs at effective doses.
- Only one clearly identified and localizable extratemporal focus of epileptiform discharges, as defined the discharges (typically epileptiform spikes) and as identified by dEEG assessment through one or more routine clinical dEEG evaluations.
- Two or more partial seizures, with or without secondary generalization, in the last month, but less than 10 seizures per day.
- Anti-seizure drug regimen has remained unchanged for the month before study entry, and there is reasonable likelihood of stability for the duration of the study, with the exception of allowing short-term rescue medications, such as lorazepam.
Key exclusion criteria (11 listed)
- Patient is pregnant or becomes pregnant
- A history or condition of progressive brain disorders, unstable systemic diseases, symptomatic cerebrovascular disease, cardiac disease, or alcohol/substance abuse.Special conditions, for example, non-malignant brain tumors and vascular malformations, can be considered for entry on a case-by-case basis.
- A history or condition of status epilepticus or psychogenic seizures (seizures not confirmed by EEG).
- Presence of a cardiac pacemaker, vagus nerve stimulator, or metal implants in the body (other than the teeth) including neurostimulators, cochlear implants, and implanted medication pumps (screened using the LCNI Safety Screening Questionaire).
- Previous surgery involving opening the skull.
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 |
|---|---|---|
| GTEN 100Also: GTENStimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day. During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days. | Device | GTEN 100 |
Primary outcome
Change in Number of Spikes Per Hour
Time frame: Baseline and following the 5 day treatment session
The main efficacy endpoint will be the change from baseline in number of spikes per hour (spike rate), as assessed with routine dEEG sessions, at each visit and after each treatment sessions.
4 secondary outcomes
Change in Seizures
Time frame: Baseline measurement and the Nine Month visit
Change in Cognitive Function Test Score
Time frame: Nine months
Change in Quality of Life Rating
Time frame: Nine months
Duration of Spike Count Suppression
Time frame: Measured at baseline. treatment and at the 9 month followup visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Don M Tucker, Ph.D principal investigator
C.E.O/, Chief Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTEN 100 in people with Epilepsy, run by Electrical Geodesics, 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 Jul 2020. 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?
Yes. Results are posted in the registry (first posted 22 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Number of Spikes Per Hour (time frame: Baseline and following the 5 day treatment session). 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 22 Jul 2020; AzTrials last refreshed its copy on 31 Oct 2026.