Effects of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Refractory Epilepsy

NCT ID: NCT04325360

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2022-12-20

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cathodal Transcranial Direct Current Stimulation (c-tDCS)

Participants in this arm of the study will receive cathode transcranial direct current stimulation.

Group Type: EXPERIMENTAL

Cathodal Transcranial Direct Current Stimulation

Intervention Type: PROCEDURE

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-tDCS

Participants in this arm of the study will receive sham transcranial direct current stimulation.

Group Type: SHAM_COMPARATOR

Sham Transcranial direct current stimulation

Intervention Type: PROCEDURE

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.

Interventions

Cathodal 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.

Intervention Type: PROCEDURE

Sham Transcranial direct current stimulation

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.

Intervention Type: PROCEDURE

Other Intervention Names

Transcranial direct current stimulation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Miriam Maria Pereira Novo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Li Min

Role: STUDY_DIRECTOR

University of Campinas, Brazil

Locations

Hospital das Clinicas - Unicamp

Campinas, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Miriam Novo

Role: CONTACT

myanovo@gmail.com

+55-19-996492458

Silvia Melo

Role: CONTACT

sefmelo@gmail.com

+55-19-981219321

Facility Contacts

Miriam Novo

Role: primary

+55-19-996492458

Other Identifiers

18938319.7.0000.5404

Identifier Type: -

Identifier Source: org_study_id