Refractory EpilepsyNCT02866240
Safety and Therapeutic Measures of Tdcs in Patients With Refractory Focal Epilepsy
A study testing Cathodal Transcranial Direct Current Stimulation (tDCS). in people with Refractory Epilepsy, run by Neuroelectrics Corporation at 1 site in United States.
Trial summary
This is a single site, non-randomized, prospective, open-label, interventional pilot/feasibility study. Patients recruited will have medically-refractory focal neocortical epilepsy, defined on the basis of presence of focal spikes and (if available) focal seizure onsets originating from the lateral cortical surface of… Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Cathodal Transcranial Direct Current Stimulation (tDCS).
- 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
- 21 Sep 2017to 31 Dec 2019
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 9 years old or older
- An established diagnosis of medically-refractory neocortical epilepsy (as determined by the referring clinician), with a clearly defined seizure focus.
- Diagnosis of epilepsy with focal seizures with or without secondary generalization (International League Against Epilepsy classification). Diagnosis established by clinical history and an electroencephalogram consistent with localization-related epilepsy.
- Continued seizures despite adequate dosage in trials of at least 2 or more antiepileptic medications within approximately the last 3 years.
- At least one clearly identified and localizable epileptogenic zone from which 80% or more seizures arise, as defined by the referring clinician.
- Currently on 1-4 anti-epileptic drugs (AEDs) with no changes in antiepileptic drug doses in the 3 weeks prior to enrollment in the study and no planned dose changes during the trial and through the primary endpoint
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- A clinical or research MRI scan that is suitable for navigated brain stimulation (NBS) and generation of electrical fields
- A reported average of at least 3 seizures per month (focal or secondarily generalized) over the three months prior to enrollment, and a minimum of 4 seizures recorded during the 8-week baseline period, with no 21-day seizure-free period during the 8 week baseline
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. All female participants of child bearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control including: oral hormonal contraceptives; implanted hormonal contraceptives, diaphragm with spermicide; condoms; intra-uterine device; abstinence.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Uncertainty regarding the diagnosis of medically-refractory epilepsy.
- History of Non-epileptic or psychogenic seizures, Primary generalized seizures, Status epilepticus in the last 12 months, Suspicion for or a significant history of syncope, Coexisting significant medical condition that is not in good control, Progressive neurologic disease, Progressive brain disorders, Serious systemic diseases, Symptomatic cerebrovascular disease, Cardiac disease, Chronic skin disease or Damaged skin on scalp that would interfere with tDCS stimulation.
- Any cranial metal implants (excluding dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator).
- Previous surgeries opening the skull.
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- Active or recent substance abuse or dependence within the past year.
- No medication is an absolute exclusion from tDCS/TMS. Medications will be reviewed and a decision about inclusion will be made based on the following: patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other central nervous system (CNS) active drugs. The published TMS guidelines review of medications to be considered with TMS will be taken into consideration.
- Any condition that makes the subject, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children´S Hospital
Boston, Massachusetts, 02115
About this study
Official title: Safety and Therapeutic Measures of Cathodal Transcranial Direct Current Stimulation (Tdcs) in Patients With Refractory Focal Epilepsy
This is a single site, non-randomized, prospective, open-label, interventional pilot/feasibility study. Patients recruited will have medically-refractory focal neocortical epilepsy, defined on the basis of presence of focal spikes and (if available) focal seizure onsets originating from the lateral cortical surface of any lobe. All patients and referring physicians will be requested to maintain their current antiepileptic drugs throughout the study with changes after enrollment permitted only to maintain pre-enrollment drug levels, or if clinically necessary. The primary outcome measure will be the change in seizure frequency (seizures/week) as compared to baseline.
Patients with medically-refractory neocortical epilepsy will receive cathodal tDCS administered to the seizure focus for 10 sessions over a 2-week period with the allowance of make-up sessions in week three. Subjects will be evaluated at baseline, during the stimulation sessions, and 8 weeks after the completion of the tDCS visits
Read the detailed description
Noninvasive neurostimulation techniques include Transcranial magnetic stimulation (TMS) and Cathodal Transcranial Direct Current Stimulation (tDCS). Of these, tDCS is uniquely suited to mass distribution and treatment, even at home, as it is lightweight, portable, inexpensive and has a favorable safety profile. In tDCS, a low intensity (1-2 mA) unidirectional electrical current is applied to the scalp to influence underlying cortical excitability. Some small preliminary studies suggest that cathodal tDCS may suppress epileptic seizures. However, a well-powered randomized-controlled trial demonstrating convincing proof of efficacy has not been conducted. This study is intended to test whether tDCS reduces seizures in patients with intractable focal neocortical epilepsy. The hypothesis is that repeated daily sessions of cathodal tDCS will lead to a clinically significant decrease in seizures in this population. Successful completion of this pilot study will be an essential first step toward a larger placebo-controlled trial with the goal of establishing cathodal tDCS as a novel, non-invasive and inexpensive treatment for drug-resistant seizures, and will provide the critical data needed for an application to obtain FDA approval for the use of tDCS in the treatment of drug-resistant epilepsy.
tDCS is a painless method for focal brain stimulation. tDCS is based on decades-old observations that neuronal firing is modulated by low amplitude electrical direct current (DC). Specifically, when applied to the cerebral cortex, cathodal DC inhibits neuronal firing. The mechanisms by which cathodal DC reduces neuronal firing likely relate to hyper-polarization of the soma membrane which occurs when the apical dendrites neuron are oriented toward the cathode in a constant electric field. The practical application of tDCS is simple: low amplitude DC is administered via scalp electrodes such that the cerebral cortex is exposed to cathodal DC beneath one of the electrodes, and the return (anodal) electrodes can be placed anywhere else on the body, or in more complex arrangements to minimize currents at any one site. tDCS methods have also recently been adapted to rats for work with disease models showing success with seizure suppression. Numerous of tDCS studies have demonstrated the technique to be well tolerated and safe. Direct electrical current stimulation is presently FDA-approved for extracranial use, and FDA applications for tDCS for management of mood disorder and chronic pain are in progress.
tDCS units are also inexpensive and light-weight. The electrical supply can be derived from conventional 9-volt batteries. The scalp electrodes can be fastened in seconds. tDCS can be combined easily with other therapies, such as those that may be required for resuscitation of an acutely-injured patient. tDCS is presently under investigation as a treatment for epilepsy, where excess cortical excitability is a prominent feature of the disease process, and where neuronal inhibition may be beneficial. Thus for epilepsy, tDCS may offer a practical non-pharmacologic therapy for the large minority, approximately 35%, of patients whose seizure cannot be controlled by medication.
The tDCS stimulator used in this clinical study is the STARSTIM device (Neuroelectrics, Inc). STARSTIM is capable of recording EEG before, during and after tDCS stimulation, and will not only allow for a detailed understanding of the tDCS-induced effect on neural activity, but may eventually serve as a guidance to fine-tune the stimulation parameters and improve the tDCS protocol based on the developmental, behavioral, dynamical, and disease state through closed-loop systems.
Starstim device is remotely controlled using NIC software that stands for Neuroelectrics Instrument Controller (NIC). This application will allow physicians to configure the study protocol with all the defined parameters. The provided version of software will only enable to apply tDCS protocols to the subjects in the study.
- Conditions
- Refractory Epilepsy
- Being tested
- Cathodal Transcranial Direct Current Stimulation (tDCS).
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathodal Transcranial Direct Current Stimulation (tDCS).Device
Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Cathodal Transcranial Direct Current Stimulation (tDCS) Receives: Device: Cathodal Transcranial Direct Current Stimulation (tDCS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency in patients with intractable focal neocortical epilepsy using cathodal tDCS.
Seizure frequency relative to pre-treatment baseline
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start21 Sep 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuroelectrics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866240
- Sponsor's protocol ID
- BCHEpilepsy
- Status last verified
- Jan 2021
- First submitted
- 5 Aug 2016
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Therapeutic Measures of Cathodal Transcranial Direct Current Stimulation (Tdcs) in Patients With Refractory Focal Epilepsy
- ClinicalTrials.gov ID
- NCT02866240
- Acronym / sponsor ID
- BCHEpilepsy
- Conditions
- Refractory Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Neuroelectrics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Beth Israel Deaconess Medical Center, Boston Children's Hospital
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Aug 2016 (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.
This is a single site, non-randomized, prospective, open-label, interventional pilot/feasibility study. Patients recruited will have medically-refractory focal neocortical epilepsy, defined on the basis of presence of focal spikes and (if available) focal seizure onsets originating from the lateral cortical surface of any lobe. All patients and referring physicians will be requested to maintain their current antiepileptic drugs throughout the study with changes after enrollment permitted only to maintain pre-enrollment drug levels, or if clinically necessary. The primary outcome measure will be the change in seizure frequency (seizures/week) as compared to baseline.
Patients with medically-refractory neocortical epilepsy will receive cathodal tDCS administered to the seizure focus for 10 sessions over a 2-week period with the allowance of make-up sessions in week three. Subjects will be evaluated at baseline, during the stimulation sessions, and 8 weeks after the completion of the tDCS visits
Detailed description
Noninvasive neurostimulation techniques include Transcranial magnetic stimulation (TMS) and Cathodal Transcranial Direct Current Stimulation (tDCS). Of these, tDCS is uniquely suited to mass distribution and treatment, even at home, as it is lightweight, portable, inexpensive and has a favorable safety profile. In tDCS, a low intensity (1-2 mA) unidirectional electrical current is applied to the scalp to influence underlying cortical excitability. Some small preliminary studies suggest that cathodal tDCS may suppress epileptic seizures. However, a well-powered randomized-controlled trial demonstrating convincing proof of efficacy has not been conducted. This study is intended to test whether tDCS reduces seizures in patients with intractable focal neocortical epilepsy. The hypothesis is that repeated daily sessions of cathodal tDCS will lead to a clinically significant decrease in seizures in this population. Successful completion of this pilot study will be an essential first step toward a larger placebo-controlled trial with the goal of establishing cathodal tDCS as a novel, non-invasive and inexpensive treatment for drug-resistant seizures, and will provide the critical data needed for an application to obtain FDA approval for the use of tDCS in the treatment of drug-resistant epilepsy.
tDCS is a painless method for focal brain stimulation. tDCS is based on decades-old observations that neuronal firing is modulated by low amplitude electrical direct current (DC). Specifically, when applied to the cerebral cortex, cathodal DC inhibits neuronal firing. The mechanisms by which cathodal DC reduces neuronal firing likely relate to hyper-polarization of the soma membrane which occurs when the apical dendrites neuron are oriented toward the cathode in a constant electric field. The practical application of tDCS is simple: low amplitude DC is administered via scalp electrodes such that the cerebral cortex is exposed to cathodal DC beneath one of the electrodes, and the return (anodal) electrodes can be placed anywhere else on the body, or in more complex arrangements to minimize currents at any one site. tDCS methods have also recently been adapted to rats for work with disease models showing success with seizure suppression. Numerous of tDCS studies have demonstrated the technique to be well tolerated and safe. Direct electrical current stimulation is presently FDA-approved for extracranial use, and FDA applications for tDCS for management of mood disorder and chronic pain are in progress.
tDCS units are also inexpensive and light-weight. The electrical supply can be derived from conventional 9-volt batteries. The scalp electrodes can be fastened in seconds. tDCS can be combined easily with other therapies, such as those that may be required for resuscitation of an acutely-injured patient. tDCS is presently under investigation as a treatment for epilepsy, where excess cortical excitability is a prominent feature of the disease process, and where neuronal inhibition may be beneficial. Thus for epilepsy, tDCS may offer a practical non-pharmacologic therapy for the large minority, approximately 35%, of patients whose seizure cannot be controlled by medication.
The tDCS stimulator used in this clinical study is the STARSTIM device (Neuroelectrics, Inc). STARSTIM is capable of recording EEG before, during and after tDCS stimulation, and will not only allow for a detailed understanding of the tDCS-induced effect on neural activity, but may eventually serve as a guidance to fine-tune the stimulation parameters and improve the tDCS protocol based on the developmental, behavioral, dynamical, and disease state through closed-loop systems.
Starstim device is remotely controlled using NIC software that stands for Neuroelectrics Instrument Controller (NIC). This application will allow physicians to configure the study protocol with all the defined parameters. The provided version of software will only enable to apply tDCS protocols to the subjects in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Cathodal Transcranial Direct Current Stimulation (tDCS).Cathodal Transcranial Direct Current Stimulation (tDCS) |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 9 years old or older
- An established diagnosis of medically-refractory neocortical epilepsy (as determined by the referring clinician), with a clearly defined seizure focus.
- Diagnosis of epilepsy with focal seizures with or without secondary generalization (International League Against Epilepsy classification). Diagnosis established by clinical history and an electroencephalogram consistent with localization-related epilepsy.
- Continued seizures despite adequate dosage in trials of at least 2 or more antiepileptic medications within approximately the last 3 years.
- At least one clearly identified and localizable epileptogenic zone from which 80% or more seizures arise, as defined by the referring clinician.
Key exclusion criteria (9 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. All female participants of child bearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control including: oral hormonal contraceptives; implanted hormonal contraceptives, diaphragm with spermicide; condoms; intra-uterine device; abstinence.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Uncertainty regarding the diagnosis of medically-refractory epilepsy.
- History of Non-epileptic or psychogenic seizures, Primary generalized seizures, Status epilepticus in the last 12 months, Suspicion for or a significant history of syncope, Coexisting significant medical condition that is not in good control, Progressive neurologic disease, Progressive brain disorders, Serious systemic diseases, Symptomatic cerebrovascular disease, Cardiac disease, Chronic skin disease or Damaged skin on scalp that would interfere with tDCS stimulation.
- Any cranial metal implants (excluding dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator).
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 |
|---|---|---|
| Cathodal Transcranial Direct Current Stimulation (tDCS).Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp. | Device | Single arm |
Primary outcome
Seizure frequency in patients with intractable focal neocortical epilepsy using cathodal tDCS.
Time frame: 8 weeks
Seizure frequency relative to pre-treatment baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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 Cathodal Transcranial Direct Current Stimulation (tDCS). in people with Refractory Epilepsy, run by Neuroelectrics Corporation 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 9 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: finished, as of the sponsor's last update on 11 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Seizure frequency in patients with intractable focal neocortical epilepsy using cathodal tDCS. (time frame: 8 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 11 Jan 2021.