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

NCT04325360 | Unknown

• 1 other identifier: 18938319.7.0000.5404
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy Intractable

Keywords

Epilepsy; transcranial direct current stimulation; seizures

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

• Changes in Cognitive function - Wechsler Adult Intelligence Scale (WAIS)

  Pre-intervention, 1 month post-intervention, 3 months post-intervention

• Positive changes in quality of life

  Pre-intervention, 1 month post-intervention, 3 months post-intervention

Study Arms (2)

Cathodal Transcranial Direct Current Stimulation (c-tDCS)

EXPERIMENTAL

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

Procedure: Cathodal Transcranial Direct Current Stimulation

Sham-tDCS

SHAM COMPARATOR

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

Procedure: Sham Transcranial direct current stimulation

Interventions

Cathodal Transcranial Direct Current Stimulation 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.

Also known as: Transcranial direct current stimulation

Cathodal Transcranial Direct Current Stimulation (c-tDCS)

Sham Transcranial direct current stimulation 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.

Sham-tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Hospital das Clinicas - Unicamp

Campinas, São Paulo, 13083-888, Brazil

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy; Seizures

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Li Li Min

  University of Campinas, Brazil

  STUDY DIRECTOR

Central Study Contacts

Miriam Novo

CONTACT

+55-19-996492458; myanovo@gmail.com

Silvia Melo

CONTACT

+55-19-981219321; sefmelo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The tDCS machine is equipped with a sham option, determined by a code, that will not be disclosed to the participants, outcome assessor and principal investigator until the moment of data analysis. Randomization will be done through envelopes that will contain the codes of types of stimulation (real vs sham), which will be prepared by a third party.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective double-blind randomized controlled trial

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: March 27, 2020
• Study Start: March 20, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2022
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)