Clinical trial NCT05825274: TDCs to Treat Drug-resistant Epilepsy
Official title: Transcranial Direct Current Estimulation for the Treatment of Drug-resistant Epilepsy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Forms of Epilepsy, Treatment Resistant
Keywords: Drug-resistant epilepsy
tDCS
Lead sponsor: Spanish Foundation for Neurometrics Development
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease in number of crisis per day
timeFrame: 4 months
measure: Body mass index
timeFrame: 4 Months
Secondary outcomes:
measure: Quality live improve
timeFrame: 4 months
measure: Kessler Foundation Neglect Assessment Process
timeFrame: 4 Months
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: New Remedies Ltd
state: Merseyside
Study officials:
affiliation: New Remedies Ltd
name: Jean Neville, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Engel J Jr. Approaches to refractory epilepsy. Ann Indian Acad Neurol. 2014 Mar;17(Suppl 1):S12-7. doi: 10.4103/0972-2327.128644.