Epilepsy IntractableNCT04325360
Effects of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Refractory Epilepsy
A study testing Cathodal Transcranial Direct Current Stimulation in people with Epilepsy Intractable, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The aim of this study is to investigate the effects of cathodal transcranial direct current stimulation in the management of seizures in subjects with focal refractory epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy Intractable
- What is being tested?
- Cathodal Transcranial Direct Current Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Mar 2020to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of focal refractory epilepsy
- participants must be 18 years or older
- must be on a stable medication regimen
- seizures frequency equal or greater than 1 seizure/month
- participants or their caregivers must be able to use a seizures diary
Who cannot join
- participants younger than 18 years old
- diagnosis of generalized epilepsy
- participants who are still making changes to medication regimen
- participants who are pregnant
- participants who have any kind of intracranial implants
- seizure frequency less than 1/month
- participants with skin abnormalities or rash on the scalp
- participants or caregivers that are unable to use a seizures diary
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas - Unicamp
Campinas, São Paulo, 13083-888
Miriam Novo, +55-19-996492458
About this study
The aim of this study is to investigate the effects of cathodal transcranial direct current stimulation in the management of seizures in subjects with focal refractory epilepsy.
Read the detailed description
Hypothesis: Epilepsy is the most common neurological disorder globally, affecting approximately 50 million people worldwide. Of these, approximately 20% present with intractable or refractory epilepsy, where the frequency of seizures cannot be controlled adequately with anti-epileptic drugs (AEDs), leading to great neurobiological, cognitive, psychological and social consequences. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation (NIBS) technique that can effectively modulate (up- or down-regulate) cortical excitability of targeted brain regions. It has the potential of downregulating the neuronal activity, through the cathodal stimulation of the epileptic focal area and thus, reducing the frequency of seizures. Previous studies have shown that cathodal tDCS is a safe and effective treatment modality of treatment to reduce the frequency of seizures in patients with refractory epilepsy. However, the level of evidence of its effects in the management of seizures frequency is still low. In the present work, the investigators aim to evaluate the effects of tDCS in the management of seizures in patients with refractory epilepsy and its impact on cognitive function and quality of life.
Objective: The main aim of this randomized controlled trial is to determine if cathodal tDCS is effective in reducing the frequency of seizures in refractory epilepsy and, to determine if this reduction will positively impact the participants cognitive status and quality of life.
Methods: This is a prospective, randomized, placebo-controlled, double-blind, single-center study. The participants in the study will be randomized to either the intervention - tDCS group or sham group. Each individual will undergo 15 consecutive sessions of real cathodal tDCS stimulation or sham-stimulation. The primary outcome measure will be the frequency of seizures, measured by a seizure diary; changes in interictal epileptiform discharges on the Electroencephalogram (EEG); and functional connectivity changes in the epilepsy focal area, measured by resting-state Functional Resonance Image (rs-fMRI). Secondary outcomes include quality of life and cognition. Outcome measures will be done prior to intervention; immediately after intervention, at 1 month-follow up and again at 3-months follow up.
- Conditions
- Epilepsy Intractable
- Being tested
- Cathodal Transcranial Direct Current Stimulation, Sham Transcranial direct current stimulation
- Keywords
- Epilepsy, transcranial direct current stimulation, seizures
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathodal Transcranial Direct Current StimulationProcedure or surgery
Also called Transcranial direct current stimulation
20 minutes of cathodal stimulation at 2mA, with cathode electrode placed over the focal epileptic area (determined by EEG exam and located according to the 10-20 system), the anode electrode will be placed over the supraorbital region, contralateral to the cathode electrode.
Sham Transcranial direct current stimulationProcedure or surgery
Participants will received 20 mins of Sham stimulation, where stimulation will happen for the first 30 seconds and in the last 30 seconds of the intervention (at 2mA), with no stimulation in the between time. The cathode electrode will be placed over the focal epileptic area (determined by EEG exam and located according to the 10-20 system),the anode electrode will be placed over the supraorbital region, contralateral to the cathode electrode.
| Study group | Role | What they receive |
|---|---|---|
| Cathodal Transcranial Direct Current Stimulation (c-tDCS) | Experimental | Participants in this arm of the study will receive cathode transcranial direct current stimulation. Receives: Procedure: Cathodal Transcranial Direct Current Stimulation |
| Sham-tDCS | Sham comparator | Participants in this arm of the study will receive sham transcranial direct current stimulation. Receives: Procedure: Sham Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in interictal epileptiform discharges on the electroencephalogram (EEG)
EEG study will be conducted to determine changes in epileptiform discharge
Measured: Pre-intervention, immediately post-intervention, 1 month post-intervention and 3 months post-intervention.
Seizures Frequency
Seizure frequency will be measured through the data analysis of a seizures diary
Measured: Pre-intervention, immediately post-intervention, 1 month post-intervention and 3 months post-intervention.
Changes in resting state connectivity through analysis of functional magnetic resonance imaging
Resting state Functional Magnetic Resonance Image to determine changes in brain functional connectivity
Measured: Pre-intervention, post-intervention, 1 month post-intervention and 3 months post-intervention
Secondary outcomes (2)
Changes in Cognitive function - Wechsler Adult Intelligence Scale (WAIS)
Neuropsychological assessment to determine changes in attention, memory, executive functions skills
Measured: Pre-intervention, 1 month post-intervention, 3 months post-intervention
Positive changes in quality of life
31-question questionnaire to determine quality of life changes specific to epilepsy
Measured: Pre-intervention, 1 month post-intervention, 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start20 Mar 2020
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy IntractableStudies 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
- Parallel groups
- Model description
- Prospective double-blind randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Maria Pereira Novo, University of Campinas, Brazil
- Investigators
- Li Li Min, Study director, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325360
- Sponsor's protocol ID
- 18938319.7.0000.5404
- Status last verified
- Mar 2020
- First submitted
- 10 Dec 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT04325360
- Acronym / sponsor ID
- 18938319.7.0000.5404
- Conditions
- Epilepsy Intractable
- Keywords
- Epilepsy, transcranial direct current stimulation, seizures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effects of cathodal transcranial direct current stimulation in the management of seizures in subjects with focal refractory epilepsy.
Detailed description
Hypothesis: Epilepsy is the most common neurological disorder globally, affecting approximately 50 million people worldwide. Of these, approximately 20% present with intractable or refractory epilepsy, where the frequency of seizures cannot be controlled adequately with anti-epileptic drugs (AEDs), leading to great neurobiological, cognitive, psychological and social consequences. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation (NIBS) technique that can effectively modulate (up- or down-regulate) cortical excitability of targeted brain regions. It has the potential of downregulating the neuronal activity, through the cathodal stimulation of the epileptic focal area and thus, reducing the frequency of seizures. Previous studies have shown that cathodal tDCS is a safe and effective treatment modality of treatment to reduce the frequency of seizures in patients with refractory epilepsy. However, the level of evidence of its effects in the management of seizures frequency is still low. In the present work, the investigators aim to evaluate the effects of tDCS in the management of seizures in patients with refractory epilepsy and its impact on cognitive function and quality of life.
Objective: The main aim of this randomized controlled trial is to determine if cathodal tDCS is effective in reducing the frequency of seizures in refractory epilepsy and, to determine if this reduction will positively impact the participants cognitive status and quality of life.
Methods: This is a prospective, randomized, placebo-controlled, double-blind, single-center study. The participants in the study will be randomized to either the intervention - tDCS group or sham group. Each individual will undergo 15 consecutive sessions of real cathodal tDCS stimulation or sham-stimulation. The primary outcome measure will be the frequency of seizures, measured by a seizure diary; changes in interictal epileptiform discharges on the Electroencephalogram (EEG); and functional connectivity changes in the epilepsy focal area, measured by resting-state Functional Resonance Image (rs-fMRI). Secondary outcomes include quality of life and cognition. Outcome measures will be done prior to intervention; immediately after intervention, at 1 month-follow up and again at 3-months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective double-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cathodal Transcranial Direct Current Stimulation (c-tDCS) | Experimental | Procedure: Cathodal Transcranial Direct Current StimulationParticipants in this arm of the study will receive cathode transcranial direct current stimulation. |
| Sham-tDCS | Sham comparator | Procedure: Sham Transcranial direct current stimulationParticipants in this arm of the study will receive sham transcranial direct current stimulation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- confirmed diagnosis of focal refractory epilepsy
- participants must be 18 years or older
- must be on a stable medication regimen
- seizures frequency equal or greater than 1 seizure/month
- participants or their caregivers must be able to use a seizures diary
Key exclusion criteria (8 listed)
- participants younger than 18 years old
- diagnosis of generalized epilepsy
- participants who are still making changes to medication regimen
- participants who are pregnant
- participants who have any kind of intracranial implants
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 StimulationAlso: Transcranial direct current stimulation20 minutes of cathodal stimulation at 2mA, with cathode electrode placed over the focal epileptic area (determined by EEG exam and located according to the 10-20 system), the anode electrode will be placed over the supraorbital region, contralateral to the cathode electrode. | Procedure or surgery | Cathodal Transcranial Direct Current Stimulation (c-tDCS) |
| Sham Transcranial direct current stimulationParticipants will received 20 mins of Sham stimulation, where stimulation will happen for the first 30 seconds and in the last 30 seconds of the intervention (at 2mA), with no stimulation in the between time. The cathode electrode will be placed over the focal epileptic area (determined by EEG exam and located according to the 10-20 system),the anode electrode will be placed over the supraorbital region, contralateral to the cathode electrode. | Procedure or surgery | Sham-tDCS |
Primary outcome
Changes in interictal epileptiform discharges on the electroencephalogram (EEG)
Time frame: Pre-intervention, immediately post-intervention, 1 month post-intervention and 3 months post-intervention.
EEG study will be conducted to determine changes in epileptiform discharge
Seizures Frequency
Time frame: Pre-intervention, immediately post-intervention, 1 month post-intervention and 3 months post-intervention.
Seizure frequency will be measured through the data analysis of a seizures diary
Changes in resting state connectivity through analysis of functional magnetic resonance imaging
Time frame: Pre-intervention, post-intervention, 1 month post-intervention and 3 months post-intervention
Resting state Functional Magnetic Resonance Image to determine changes in brain functional connectivity
2 secondary outcomes
Changes in Cognitive function - Wechsler Adult Intelligence Scale (WAIS)
Time frame: Pre-intervention, 1 month post-intervention, 3 months post-intervention
Positive changes in quality of life
Time frame: Pre-intervention, 1 month post-intervention, 3 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Epilepsy Intractable
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Recruiting
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
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.
Li Li Min study director
University of Campinas, Brazil
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 in people with Epilepsy Intractable, run by University of Campinas, Brazil at 1 site in Brazil.
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 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 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 Brazil. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Novo (+55-19-996492458, myanovo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in interictal epileptiform discharges on the electroencephalogram (EEG) (time frame: Pre-intervention, immediately post-intervention, 1 month post-intervention and 3 months post-intervention.). The study lists 3 primary outcomes in all. 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 27 Mar 2020.