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

Epilepsy Intractable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04325360
• Other study ID #: 18938319.7.0000.5404
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: March 2020
• Source: University of Campinas, Brazil
• Contact: Miriam Novo
• Phone: +55-19-996492458
• Email: myanovo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Epilepsy Intractable

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - Unicamp	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in interictal epileptiform discharges on the electroencephalogram (EEG)	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.
Primary	Seizures Frequency	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.
Primary	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	Pre-intervention, post-intervention, 1 month post-intervention and 3 months post-intervention
Secondary	Changes in Cognitive function - Wechsler Adult Intelligence Scale (WAIS)	Neuropsychological assessment to determine changes in attention, memory, executive functions skills	Pre-intervention, 1 month post-intervention, 3 months post-intervention
Secondary	Positive changes in quality of life	31-question questionnaire to determine quality of life changes specific to epilepsy	Pre-intervention, 1 month post-intervention, 3 months post-intervention