Refractory EpilepsyPhase 2NCT01763294
A Controlled Clinical Trial of Cathodal Transcranial Direct Current Stimulation in Patients With Refractory Epilepsy
A Phase 2 study testing Nicolet Endeavor CR: 30min, Nicolet Endeavor CR: 60min and Nicolet Endeavor CR: 30min for 3 days in people with Refractory Epilepsy, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
Trial summary
There is a continuous necessity for the search of new alternatives for safe, affordable and effective noninvasive therapies for patients that are not eligible for focal resective or palliative surgery. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Nicolet Endeavor CR: 30min, Nicolet Endeavor CR: 60min and Nicolet Endeavor CR: 30min for 3 days
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2012to Apr 2015
- Phase
- Phase 2
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any gender
- age ≥ 15 and <65 years
- Refractory epilepsy characterized by 3 or more seizures by month and the right use of 2 or more antiepileptic drugs during the last 12 months
- Not eligible for surgery treatment
- Right attachment to the antiepileptic treatment established at least 12 months before the date of inclusion
- Multifocal epilepsy defined as 2 or more lobar regions affected with epileptic activity
Who cannot join
- Patients with pseudoseizures
- Previous craniotomy
- Active local infection of the skull
- Informed consent not signed
- Patients with generalized idiopathic epilepsy or focal idiopathic epilepsy
- Patients in stupor or coma
Show all 9Show fewer
- Patients in lactation or pregnancy
- Patients with chronic degenerative diseases of the nervous system
- Patients with exacerbated chronic degenerative diseases
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico City, 14269
About this study
There is a continuous necessity for the search of new alternatives for safe, affordable and effective noninvasive therapies for patients that are not eligible for focal resective or palliative surgery. The transcranial direct current stimulation (tDCS) therapy has demonstrated to be safe, noninvasive, simple and effective with promising results in case series, case reports and animals models for the treatment of intractable epilepsy. tDCS is a feasible and low cost method to modify cortical excitability in a non-invasive procedure. Its effects on cortical excitability seem to be similar to the effects induced by repetitive transcranial magnetic stimulation. The aim of this study is determine the safety and efficacy in the reduction of the number of seizures (>50%) and epileptiform activity in patients with refractory and multifocal epilepsy after different protocols of tDCS compared with placebo.
Read the detailed description
This is a prospective interventional clinical study. All enrolled patients have multifocal and refractory epilepsy that voluntarily will accept to participate in the study signing a consent informed form. All patients are from the epilepsy clinic our Institute that meet the criteria. All patients will be randomized and divided in 5 groups (45 patients); placebo group, active group of one session 30 minutes, active group of one session of 60 minutes, active group of 30 minutes for 3 consecutively days and 30 minutes for 5 consecutively days. After the selection, the patients will record their EEG of 30 min in order to register the basal epileptic activity and determine the most epileptic area, where the intervention will be applied. Then, an EEG will be realized after the intervention, one month after and two months after.
The equipment used to apply the therapy is approved for medical use in our country. The equipment is Nicolet, Endeavor used at low amplitude for direct electrical nervous stimulation mode. The intensity to apply will be 2 milliampere. The stimulation mode is continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings, nevertheless, it is ruled by the international EEG 10/20 system.
The cathodal electrode is applies with disposable needle of 12 mm long and 0.5 mm wide, while the anodal electrode is applied with conventional cup electrodes with a 2mm hole in the center an a recording surface of silver chloride /silver. After the intervention the patient is asked about any adverse effect form the therapy application and the EEG is realized as the investigators described before. The patient will receive a follow up dates at one and two months. The patient must make a calendar with the frequency of seizures and must not change the actual medication.
Placebo. This group receives the same procedures just that in this case the machine produces a 60 second stimulus at the beginning so the patient can feel the initial electric stimulus.
The investigators will record the frequency of the seizures and analysis of the epileptiform activity in the EEGs in the baseline, after therapy, 1 month and 2 months of follow-up. As well the safety profile of the tDCS.
- Conditions
- Refractory Epilepsy
- Being tested
- Nicolet Endeavor CR: 30min, Nicolet Endeavor CR: 60min, Nicolet Endeavor CR: 30min for 3 days, Nicolet Endeavor CR: 30min for 5 days, Nicolet Endeavor CR: Placebo
- Keywords
- multifocal refractory epilepsy, tDCS, neurostimulation, seizures
- Medical subject headings
- Drug Resistant Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicolet Endeavor CR: 30minDevice
Also called tdcs
Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.
Nicolet Endeavor CR: 60minDevice
Also called tdcs
Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.
Nicolet Endeavor CR: 30min for 3 daysDevice
Also called tdcs
Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.
Nicolet Endeavor CR: 30min for 5 daysDevice
Also called tdcs
Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.
Nicolet Endeavor CR: PlaceboDevice
Also called placebo
The same procedures just that in this case the machine produces only a 60 second stimulus at the beginning so the patient can feel the initial electric stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Nicolet Endeavor CR: 30min | Active comparator | Apply 1 session of 2 milliampere intensity for 30 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system. Receives: Device: Nicolet Endeavor CR: 30min |
| Nicolet Endeavor CR: 60min | Active comparator | Apply 1 session of 2 milliampere intensity for 60 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system. Receives: Device: Nicolet Endeavor CR: 60min |
| Nicolet Endeavor CR: 30min for 3 days | Active comparator | Apply 3 sessions of 2 milliampere intensity for 30 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system. Receives: Device: Nicolet Endeavor CR: 30min for 3 days |
| Nicolet Endeavor CR: 30min for 5 days | Active comparator | Apply 5 sessions of 2 milliampere intensity for 30 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system. Receives: Device: Nicolet Endeavor CR: 30min for 5 days |
| Nicolet Endeavor CR: Placebo | Placebo comparator | The same procedures just that in this case the machine produces only a 60 second stimulus at the beginning so the patient can feel the initial electric stimulus. Receives: Device: Nicolet Endeavor CR: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seizures
The number of the seizures monthly for 2 months
Measured: 2 months
Secondary outcomes (2)
Frequency of epileptiform discharges
The frequency of the epileptiform discharges on EEGs evaluate at the baseline, after therapy, 1 and 2 months.
Measured: 2 months
Amplitude of epileptiform discharges
Amplitude of the epileptiform discharges on EEGs evaluate at the baseline, after therapy, 1 and 2 months.
Measured: 2 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, University Hospital Freiburg, Spaulding Rehabilitation Hospital
- Responsible party
- Principal investigator, DANIEL SAN JUAN ORTA, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Investigators
- Daniel San-juan, MD, Principal investigator, Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763294
- Sponsor's protocol ID
- 04/10
- Status last verified
- Apr 2015
- First submitted
- 2 Jan 2013
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
San-Juan D, Calcaneo Jde D, Gonzalez-Aragon MF, Bermudez Maldonado L, Avellan AM, Argumosa EV, Fregni F. Transcranial direct current stimulation in adolescent and adult Rasmussen's encephalitis. Epilepsy Behav. 2011 Jan;20(1):126-31. doi: 10.1016/j.yebeh.2010.10.031. Epub 2010 Dec 17.
PubMed 21167786Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x.
PubMed 16499758San-Juan D, Espinoza Lopez DA, Vazquez Gregorio R, Trenado C, Fernandez-Gonzalez Aragon M, Morales-Quezada L, Hernandez Ruiz A, Hernandez-Gonzalez F, Alcaraz-Guzman A, Anschel DJ, Fregni F. Transcranial Direct Current Stimulation in Mesial Temporal Lobe Epilepsy and Hippocampal Sclerosis. Brain Stimul. 2017 Jan-Feb;10(1):28-35. doi: 10.1016/j.brs.2016.08.013. Epub 2016 Aug 31.
PubMed 27693237
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Trial of Cathodal Transcranial Direct Current Stimulation in Patients With Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT01763294
- Acronym / sponsor ID
- 04/10
- Conditions
- Refractory Epilepsy
- Keywords
- multifocal refractory epilepsy, tDCS, neurostimulation, seizures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, University Hospital Freiburg, Spaulding Rehabilitation Hospital
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Jan 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.
There is a continuous necessity for the search of new alternatives for safe, affordable and effective noninvasive therapies for patients that are not eligible for focal resective or palliative surgery. The transcranial direct current stimulation (tDCS) therapy has demonstrated to be safe, noninvasive, simple and effective with promising results in case series, case reports and animals models for the treatment of intractable epilepsy. tDCS is a feasible and low cost method to modify cortical excitability in a non-invasive procedure. Its effects on cortical excitability seem to be similar to the effects induced by repetitive transcranial magnetic stimulation. The aim of this study is determine the safety and efficacy in the reduction of the number of seizures (>50%) and epileptiform activity in patients with refractory and multifocal epilepsy after different protocols of tDCS compared with placebo.
Detailed description
This is a prospective interventional clinical study. All enrolled patients have multifocal and refractory epilepsy that voluntarily will accept to participate in the study signing a consent informed form. All patients are from the epilepsy clinic our Institute that meet the criteria. All patients will be randomized and divided in 5 groups (45 patients); placebo group, active group of one session 30 minutes, active group of one session of 60 minutes, active group of 30 minutes for 3 consecutively days and 30 minutes for 5 consecutively days. After the selection, the patients will record their EEG of 30 min in order to register the basal epileptic activity and determine the most epileptic area, where the intervention will be applied. Then, an EEG will be realized after the intervention, one month after and two months after.
The equipment used to apply the therapy is approved for medical use in our country. The equipment is Nicolet, Endeavor used at low amplitude for direct electrical nervous stimulation mode. The intensity to apply will be 2 milliampere. The stimulation mode is continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings, nevertheless, it is ruled by the international EEG 10/20 system.
The cathodal electrode is applies with disposable needle of 12 mm long and 0.5 mm wide, while the anodal electrode is applied with conventional cup electrodes with a 2mm hole in the center an a recording surface of silver chloride /silver. After the intervention the patient is asked about any adverse effect form the therapy application and the EEG is realized as the investigators described before. The patient will receive a follow up dates at one and two months. The patient must make a calendar with the frequency of seizures and must not change the actual medication.
Placebo. This group receives the same procedures just that in this case the machine produces a 60 second stimulus at the beginning so the patient can feel the initial electric stimulus.
The investigators will record the frequency of the seizures and analysis of the epileptiform activity in the EEGs in the baseline, after therapy, 1 month and 2 months of follow-up. As well the safety profile of the tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nicolet Endeavor CR: 30min | Active comparator | Device: Nicolet Endeavor CR: 30minApply 1 session of 2 milliampere intensity for 30 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system. |
| Nicolet Endeavor CR: 60min | Active comparator | Device: Nicolet Endeavor CR: 60minApply 1 session of 2 milliampere intensity for 60 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system. |
| Nicolet Endeavor CR: 30min for 3 days | Active comparator | Device: Nicolet Endeavor CR: 30min for 3 daysApply 3 sessions of 2 milliampere intensity for 30 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system. |
| Nicolet Endeavor CR: 30min for 5 days | Active comparator | Device: Nicolet Endeavor CR: 30min for 5 daysApply 5 sessions of 2 milliampere intensity for 30 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system. |
| Nicolet Endeavor CR: Placebo | Placebo comparator | Device: Nicolet Endeavor CR: PlaceboThe same procedures just that in this case the machine produces only a 60 second stimulus at the beginning so the patient can feel the initial electric stimulus. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- any gender
- age ≥ 15 and <65 years
- Refractory epilepsy characterized by 3 or more seizures by month and the right use of 2 or more antiepileptic drugs during the last 12 months
- Not eligible for surgery treatment
- Right attachment to the antiepileptic treatment established at least 12 months before the date of inclusion
Key exclusion criteria (9 listed)
- Patients with pseudoseizures
- Previous craniotomy
- Active local infection of the skull
- Informed consent not signed
- Patients with generalized idiopathic epilepsy or focal idiopathic epilepsy
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 |
|---|---|---|
| Nicolet Endeavor CR: 30minAlso: tdcsTranscranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation. | Device | Nicolet Endeavor CR: 30min |
| Nicolet Endeavor CR: 60minAlso: tdcsTranscranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation. | Device | Nicolet Endeavor CR: 60min |
| Nicolet Endeavor CR: 30min for 3 daysAlso: tdcsTranscranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation. | Device | Nicolet Endeavor CR: 30min for 3 days |
| Nicolet Endeavor CR: 30min for 5 daysAlso: tdcsTranscranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation. | Device | Nicolet Endeavor CR: 30min for 5 days |
| Nicolet Endeavor CR: PlaceboAlso: placeboThe same procedures just that in this case the machine produces only a 60 second stimulus at the beginning so the patient can feel the initial electric stimulus. | Device | Nicolet Endeavor CR: Placebo |
Primary outcome
Number of seizures
Time frame: 2 months
The number of the seizures monthly for 2 months
2 secondary outcomes
Frequency of epileptiform discharges
Time frame: 2 months
Amplitude of epileptiform discharges
Time frame: 2 monts
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 7 Apr 2015.
- Results publication: PubMed 21167786San-Juan D, Calcaneo Jde D, Gonzalez-Aragon MF, Bermudez Maldonado L, Avellan AM, Argumosa EV, Fregni F. Transcranial direct current stimulation in adolescent and adult Rasmussen's encephalitis. Epilepsy Behav. 2011 Jan;20(1):126-31. doi: 10.1016/j.yebeh.2010.10.031. Epub 2010 Dec 17.
- Results publication: PubMed 16499758Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x.
- Derived from this study: PubMed 27693237San-Juan D, Espinoza Lopez DA, Vazquez Gregorio R, Trenado C, Fernandez-Gonzalez Aragon M, Morales-Quezada L, Hernandez Ruiz A, Hernandez-Gonzalez F, Alcaraz-Guzman A, Anschel DJ, Fregni F. Transcranial Direct Current Stimulation in Mesial Temporal Lobe Epilepsy and Hippocampal Sclerosis. Brain Stimul. 2017 Jan-Feb;10(1):28-35. doi: 10.1016/j.brs.2016.08.013. Epub 2016 Aug 31.
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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.
Daniel San-juan, MD principal investigator
Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicolet Endeavor CR: 30min, Nicolet Endeavor CR: 60min and Nicolet Endeavor CR: 30min for 3 days in people with Refractory Epilepsy, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
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 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 7 Apr 2015. 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 Mexico. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of seizures (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01763294, which also lists 3 linked publications.
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 7 Apr 2015.