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

March 26, 2020 updated by: Miriam Maria Pereira Novo, University of Campinas, Brazil
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-888
        • Recruiting
        • Hospital das Clinicas - UNICAMP
        • Contact:
          • Miriam Novo
          • Phone Number: +55-19-996492458

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cathodal Transcranial Direct Current Stimulation (c-tDCS)
Participants in this arm of the study will receive cathode transcranial direct current stimulation.
Procedure: 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.
Other Names:
  • Transcranial direct current stimulation
SHAM_COMPARATOR: Sham-tDCS
Participants in this arm of the study will receive sham transcranial direct current stimulation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-intervention, immediately post-intervention, 1 month post-intervention and 3 months post-intervention.
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
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
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
Pre-intervention, post-intervention, 1 month post-intervention and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Cognitive function - Wechsler Adult Intelligence Scale (WAIS)
Time Frame: Pre-intervention, 1 month post-intervention, 3 months post-intervention
Neuropsychological assessment to determine changes in attention, memory, executive functions skills
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
31-question questionnaire to determine quality of life changes specific to epilepsy
Pre-intervention, 1 month post-intervention, 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

  • Study Director: Li Li Min, University of Campinas, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2020

Primary Completion (ANTICIPATED)

December 20, 2021

Study Completion (ANTICIPATED)

December 20, 2022

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

March 26, 2020

First Posted (ACTUAL)

March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18938319.7.0000.5404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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