TDCs to Treat Drug-resistant Epilepsy

Transcranial Direct Current Estimulation for the Treatment of Drug-resistant Epilepsy in Children

Epilepsy is the fourth overall neurologic disorder, regardless of age and gender. It encompass a wide spectrum of conditions, intensities and seizure types; therefor, several drugs have proven to treat different types of seizures. However, around 22.5 % of patients are unable to attain control regardless of the drug used or even a combination of several of them. TDCs offers a non-invasive approach with a focal effect for those patients. The focus of this study is to define the role for tDCS in the treatment of drug-resistant epilepsy on children.

Study Overview

• Status: Completed
• Conditions: Other Forms of Epilepsy, Treatment Resistant
• Intervention / Treatment: Device: Cathodal tDCS

Detailed Description

Epilepsy is the fourth overall neurologic disorder, regardless of age and gender. There are between 16 and 51 new cases per 100 000 people every year. A community-based study conducted in France concluded that up to 22.5 % of patients could be classified as presenting drug-resistant epilepsy. This group presents significant hazards such as an increased risk of death, injuries, psychosocial disfunction and a reduced quality of life. The International League against Epilepsy defines drug-resistant epilepsy as follows: A failure of adequate trials of two (or more) tolerated, appropriately chosen, appropriately used antiepileptic drugs (whether administered as monotherapies or in a combination) to achieve freedom from seizures. This significant amount of patients are the drive to develop different approaches in order to offer alternatives for control. In this regard, non-invasive brain stimulation protocols lead the way, since the pathophysiological substrate of epilepsy is an enhanced cortical excitability, leading to paroxysmal depolarisation shifts, an enhanced probability of high-frequent and hypersyncronous activity of small neuronal networks and the abnormal spreading of this pathological activity along cortico-cortical and cortico-subcortical neuronal conections. Transcranial direct current stimulation (tDCS) consists of short-lasting electric stimulus delivered to specific brain regions. When delivered repidetly, it generates long-lasting cortical excitability alterations and thus, has the potential to treat epilepsy targeting to the specific brain region where the cortical excitability is alterated. The aim of this study is to define the role for tDCS on the treatment of drug resistant epilepsy on children.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L1 0AH
      • New Remedies Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-90 montths
• Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
• At least 2-3 seizure per month documented with EEG, not only clinically.
• In good health except epilepsy.
• Patients or his(her) familys could understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up.

Exclusion Criteria:

• Results of MRI remind epilepsy caused by intracranial space-occupying lesions.
• Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication
• sleep-related breathing disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Refractory Epilepsy Group; 50 patients with at least they have 3 crisis per week They Receive Cathodal tDCS We do EEG before and after intervention with 19 channels and the patient complete questionnarie: QUALITY OF LIFE IN EPILEPSY - QOLIE-31	Device: Cathodal tDCS; We do 2 sessions per week of 35 minutes with cathodal electrodes over epileptic focus; Other Names: tDCS; Brain Noninvasive Electrical Stimulation
Placebo Comparator: Placebo Patients; 50 patients with at least they have 3 crisis per week that receive SHAM They Not Receive Cathodal tDCS. We do EEG before and after intervention with 19 channels and the patient complete questionnarie: QUALITY OF LIFE IN EPILEPSY - QOLIE-31	Device: Cathodal tDCS; We do 2 sessions per week of 35 minutes with cathodal electrodes over epileptic focus; Other Names: tDCS; Brain Noninvasive Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in number of crisis per day	Improve epilepsy and EEG (NO statistically and clinically significant spikes or slow waves were observed in EEG)., and changes in scale: QUALITY OF LIFE IN EPILEPSY - QOLIE-31	4 months
Body mass index	kg / m^2	4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality live improve	less drugs consum and number of crisis per week, or moderate changes in EEG or brainwaves	4 months
Kessler Foundation Neglect Assessment Process	During each assessment session, occupational therapists measured patients' functions with the KF-NAP, Functional Independence Measure (FIM™) and Barthel Index (BI)	4 Months

Collaborators and Investigators

• Sponsor: Spanish Foundation for Neurometrics Development
• Investigators: Study Director: Jean Neville, MD, New Remedies Ltd

Publications and helpful links

General Publications

• Varga ET, Terney D, Atkins MD, Nikanorova M, Jeppesen DS, Uldall P, Hjalgrim H, Beniczky S. Transcranial direct current stimulation in refractory continuous spikes and waves during slow sleep: a controlled study. Epilepsy Res. 2011 Nov;97(1-2):142-5. doi: 10.1016/j.eplepsyres.2011.07.016. Epub 2011 Aug 31.
• Strzelczyk A, Griebel C, Lux W, Rosenow F, Reese JP. The Burden of Severely Drug-Refractory Epilepsy: A Comparative Longitudinal Evaluation of Mortality, Morbidity, Resource Use, and Cost Using German Health Insurance Data. Front Neurol. 2017 Dec 22;8:712. doi: 10.3389/fneur.2017.00712. eCollection 2017.
• Engel J Jr. Approaches to refractory epilepsy. Ann Indian Acad Neurol. 2014 Mar;17(Suppl 1):S12-7. doi: 10.4103/0972-2327.128644.

Helpful Links

• Transcranial Direct Current Stimulation for Treatment of Refractory Childhood Focal Epilepsy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 28, 2017

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: tDCS; Drug-resistant epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: RefEpTDCs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: neuroterapias.es is the database where our foundation recorda all the clinical data of our assays
• IPD Sharing Time Frame: 4 Months
• IPD Sharing Access Criteria: login and password previous registration in neuroterapias.es
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No