EpilepsyTMSNCT02757547
Transcranial Magnetic Stimulation for Epilepsy
A study testing Transcranial magnetic stimulation - Active Arm in people with Epilepsy, run by Electrical Geodesics, Inc..
Trial summary
The goal of the present clinical trial is to determine whether low frequency (0.5 Hz) rTMS can induce long term depression in epileptogenic cortex and thus suppress cortical excitability at the epileptic focus. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Transcranial magnetic stimulation - Active Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 15 Nov 2017
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Failure of adequate seizure control with prior use of at least 2 anti-seizure drugs.
- at least one clearly identified and localizable likely seizure onset focus, as defined by the discharges (typically epileptiform spikes) and as identified by dEEG assessment through one or more routine clinical dEEG evaluations. This focus must be 2 to 3 cm from the head surface (to be reachable by TMS). Where multiple spike foci are present and meet these criteria, then the focus with either clinically relevant symptoms or the most spikes (or both) will be chosen as the target for treatment.
- 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.
- age of 22 years and older.
Who cannot join
- If of childbearing potential, the patient must agree to use an effective method of birth control during the study and cease participation if pregnant.
- Nursing mothers are excluded.
- A history or condition of progressive brain disorders, serious systemic diseases, symptomatic cerebrovascular disease, cardiac disease, or alcohol abuse. Special conditions, for example, non-malignant brain tumors and vascular malformations, can be considered for entry on a case-by-case basis. Patients are not excluded on the basis of previous psychiatric hospitalizations or suicide attempts.
- A history or condition of (generalized) status epilepticus or psychogenic seizures.
- Presence of a cardiac pacemaker, vagus nerve stimulator, or metal implantation in the body (other than the teeth) including neurostimulators, cochlear implants, and implanted medication pumps.
- Previous surgery involving opening the skull.
- Unable to express presence of pain or discomfort.
About this study
Official title: Registered Electrical Sources for Effective TMS Treatment of Epilepsy
The goal of the present clinical trial is to determine whether low frequency (0.5 Hz) rTMS can induce long term depression in epileptogenic cortex and thus suppress cortical excitability at the epileptic focus.
Read the detailed description
Investigators propose a safety and feasibility trial for treating epilepsy (Transcranial Magnetic Stimulation for Epilepsy. Principal Investigator: Robert Fisher, MD, PhD, Stanford University). In this approach, the cortical source of epileptic discharges is first localized with dense array electroencephalography (256-channel dEEG). This localization is then registered with neuronavigator software to allow precise targeting with slow (0. 5 Hz) repetitive Transcranial Magnetic Stimulation (rTMS) with the STM9000. The purpose in the feasibility study is to introduce Long Term Depression (LTD) of the seizure onset zone in order to reduce epileptiform discharges. The goal in the future pivotal trial will be to extend this approach to suppress seizures. The funds for this trial are provided by Stanford University. A loan of dEEG equipment and consulting are provided by Electrical Geodesics, Inc. (EGI). EGI seeks FDA's approval for this trial. EGI is the manufacturer of the dEEG system (GES 400) and the US distributor of the EB Neuro STM9000 rTMS system (manufactured in Italy by EB Neuro, S.p.A.).
The eventual goal will be a pivotal trial for a de novo 510k for dEEG-guided rTMS for suppressing epileptic seizures. The more limited goal of suppressing epileptic discharges (spikes) will allow careful evaluation of safety while demonstrating feasibility of the therapeutic action. In preparing this request, the investigators have studied the guidance on the special controls described for rTMS in the FDA Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems, Document issued on: July 26, 2011. In addition, because patients with epilepsy are at particular risk of seizures that may be induced or exacerbated by rTMS, investigators also address the unique risks of this population, the existing evidence on safety and efficacy of rTMS treatment of the epileptic focus, and the mitigation the investigators propose to minimize the risks.
EGI has received an IDE for a safety and feasibility trial for treating epileptic discharges with a different method and device, the Geodesic Transcranial Electrical Neuromodulation (GTEN 100) system. The primary difference in the present proposal is the use of rTMS (instead of the GTEN 100) to induce long term depression and thus suppression of the cortical excitability at the epileptic focus. Dr. Robert Fisher, the Principal Investigator on this project, is EGI's unpaid consultant. Dr. Fisher has received an IRB approval at Stanford University Hospital for the larger study with this title for 10 patients with dEEG-guided rTMS treatment of focal epilepsy with the GES 400 and STM9000. The present trial is a safety and feasibility study with 10 patients that will be conducted with an informed consent form that is now specific to this safety and feasibility study.
- Conditions
- Epilepsy
- Being tested
- Transcranial magnetic stimulation - Placebo Arm, Transcranial magnetic stimulation - Active Arm
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation - Placebo ArmDevice
Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation.
Transcranial magnetic stimulation - Active ArmDevice
Also called STM9000 Transcranial Magnetic Stimulator
Each seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial magnetic stimulation - Placebo Arm | Placebo comparator | A placebo TMS coil is used. Receives: Device: Transcranial magnetic stimulation - Placebo Arm |
| Transcranial magnetic stimulation - Active Arm | Active comparator | An active TMS coil is used. Receives: Device: Transcranial magnetic stimulation - Active Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of Seizure Frequency
The primary outcome was determined to be measured by the reduction in seizure frequency compared to baseline.
Measured: Placebo compared to Active
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startSep 2015
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Electrical Geodesics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Robert S Fisher, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757547
- Sponsor's protocol ID
- IDEG150216
- Acronym
- TMS
- Status last verified
- Jul 2019
- First submitted
- 19 Apr 2016
- Last updated
- 23 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registered Electrical Sources for Effective TMS Treatment of Epilepsy
- ClinicalTrials.gov ID
- NCT02757547
- Acronym / sponsor ID
- TMS / IDEG150216
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to discontinue development of this investigational device.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Electrical Geodesics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- Sep 2015
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the present clinical trial is to determine whether low frequency (0.5 Hz) rTMS can induce long term depression in epileptogenic cortex and thus suppress cortical excitability at the epileptic focus.
Detailed description
Investigators propose a safety and feasibility trial for treating epilepsy (Transcranial Magnetic Stimulation for Epilepsy. Principal Investigator: Robert Fisher, MD, PhD, Stanford University). In this approach, the cortical source of epileptic discharges is first localized with dense array electroencephalography (256-channel dEEG). This localization is then registered with neuronavigator software to allow precise targeting with slow (0. 5 Hz) repetitive Transcranial Magnetic Stimulation (rTMS) with the STM9000. The purpose in the feasibility study is to introduce Long Term Depression (LTD) of the seizure onset zone in order to reduce epileptiform discharges. The goal in the future pivotal trial will be to extend this approach to suppress seizures. The funds for this trial are provided by Stanford University. A loan of dEEG equipment and consulting are provided by Electrical Geodesics, Inc. (EGI). EGI seeks FDA's approval for this trial. EGI is the manufacturer of the dEEG system (GES 400) and the US distributor of the EB Neuro STM9000 rTMS system (manufactured in Italy by EB Neuro, S.p.A.).
The eventual goal will be a pivotal trial for a de novo 510k for dEEG-guided rTMS for suppressing epileptic seizures. The more limited goal of suppressing epileptic discharges (spikes) will allow careful evaluation of safety while demonstrating feasibility of the therapeutic action. In preparing this request, the investigators have studied the guidance on the special controls described for rTMS in the FDA Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems, Document issued on: July 26, 2011. In addition, because patients with epilepsy are at particular risk of seizures that may be induced or exacerbated by rTMS, investigators also address the unique risks of this population, the existing evidence on safety and efficacy of rTMS treatment of the epileptic focus, and the mitigation the investigators propose to minimize the risks.
EGI has received an IDE for a safety and feasibility trial for treating epileptic discharges with a different method and device, the Geodesic Transcranial Electrical Neuromodulation (GTEN 100) system. The primary difference in the present proposal is the use of rTMS (instead of the GTEN 100) to induce long term depression and thus suppression of the cortical excitability at the epileptic focus. Dr. Robert Fisher, the Principal Investigator on this project, is EGI's unpaid consultant. Dr. Fisher has received an IRB approval at Stanford University Hospital for the larger study with this title for 10 patients with dEEG-guided rTMS treatment of focal epilepsy with the GES 400 and STM9000. The present trial is a safety and feasibility study with 10 patients that will be conducted with an informed consent form that is now specific to this safety and feasibility study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial magnetic stimulation - Placebo Arm | Placebo comparator | Device: Transcranial magnetic stimulation - Placebo ArmA placebo TMS coil is used. |
| Transcranial magnetic stimulation - Active Arm | Active comparator | Device: Transcranial magnetic stimulation - Active ArmAn active TMS coil is used. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Failure of adequate seizure control with prior use of at least 2 anti-seizure drugs.
- at least one clearly identified and localizable likely seizure onset focus, as defined by the discharges (typically epileptiform spikes) and as identified by dEEG assessment through one or more routine clinical dEEG evaluations. This focus must be 2 to 3 cm from the head surface (to be reachable by TMS). Where multiple spike foci are present and meet these criteria, then the focus with either clinically relevant symptoms or the most spikes (or both) will be chosen as the target for treatment.
- 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.
Key exclusion criteria (7 listed)
- If of childbearing potential, the patient must agree to use an effective method of birth control during the study and cease participation if pregnant.
- Nursing mothers are excluded.
- A history or condition of progressive brain disorders, serious systemic diseases, symptomatic cerebrovascular disease, cardiac disease, or alcohol abuse. Special conditions, for example, non-malignant brain tumors and vascular malformations, can be considered for entry on a case-by-case basis. Patients are not excluded on the basis of previous psychiatric hospitalizations or suicide attempts.
- A history or condition of (generalized) status epilepticus or psychogenic seizures.
- Presence of a cardiac pacemaker, vagus nerve stimulator, or metal implantation in the body (other than the teeth) including neurostimulators, cochlear implants, and implanted medication pumps.
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 |
|---|---|---|
| Transcranial magnetic stimulation - Placebo ArmEach seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation. | Device | Transcranial magnetic stimulation - Placebo Arm |
| Transcranial magnetic stimulation - Active ArmAlso: STM9000 Transcranial Magnetic StimulatorEach seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. | Device | Transcranial magnetic stimulation - Active Arm |
Primary outcome
Suppression of Seizure Frequency
Time frame: Placebo compared to Active
The primary outcome was determined to be measured by the reduction in seizure frequency compared to baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert S Fisher, Ph.D. principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation - Active Arm in people with Epilepsy, run by Electrical Geodesics, Inc..
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 7 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 20 Aug 2019). 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?
Suppression of Seizure Frequency (time frame: Placebo compared to Active). 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 23 Jul 2020.