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Completed

NCT Number: NCT05825274

TDCs to Treat Drug-resistant Epilepsy

Epilepsy is the fourth overall neurologic disorder, regardless of age and gender, affecting more than 50 million people worldwide. Modern epidemiological studies indicate that the global annualized cumulative incidence ranges between 42.8 and 67.8 new cases per 100,000 people each year, with figures scaling up to 139 per 100,000 in low- and middle-income regions. 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 dysfunction, and a reduced quality of life.

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Key information

Conditions

Other Forms of Epilepsy, Treatment Resistant Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

18 month–120 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bigdata4brain LTD

Liverpool, Merseyside, L1 0AH, United Kingdom

About this study

The International League Against Epilepsy (ILAE) 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 is 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 depolarization shifts, an enhanced probability of high-frequency and hypersynchronous activity of small neuronal networks, and the abnormal spreading of this pathological activity along cortico-cortical and cortico-subcortical neuronal connections.Transcranial direct current stimulation (tDCS) consists of short-lasting electric stimulus delivered to specific brain regions. When delivered repeatedly, it generates long-lasting cortical excitability shifts through mechanisms resembling long-term depression (LTD). In this study, cathodal tDCS (c-tDCS) is utilized to apply a hyperpolarizing current directly over the primary epileptogenic focus, aiming to suppress pathological network activity and reduce seizure frequency in pediatric patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients aged between 4 and 6 years at the time of screening.
  • Formally diagnosed with drug-resistant focal epilepsy according to the International League Against Epilepsy (ILAE) criteria (failure of adequate trials of two or more tolerated, appropriately chosen, and appropriately used antiepileptic drug regimens).
  • Experiencing a baseline frequency of at least 3 clinical seizures per week, documented via a reliable prospective seizure diary kept by parents or caregivers.
  • Patients whose legal guardians are willing and able to provide written informed consent, and patients who can provide assent when age-appropriate.

Exclusion criteria

  • Presence of metallic implants in the brain or skull (e.g., surgical clips, cochlear implants) near the site of electrode placement.
  • History of severe cardiac arrhythmias, unstable cardiovascular disease, or baseline pacemaker dependent, which may compromise safety during Heart Rate Variability (HRV) monitoring.
  • Progressive neurological disorders, neurodegenerative diseases, or active brain tumors.
  • Recent changes in antiepileptic drug (AED) dosages or types within the 4 weeks prior to baseline screening.
  • Any active skin lesions, inflammation, or structural cranial abnormalities at the target electrode site that prevent safe application of the tDCS pads.
  • Current participation in another clinical trial involving investigational drugs or neurostimulation devices.

Treatment and study plan

Active Cathodal tDCS

Device

Active cathodal stimulation delivered at twice-weekly intervals. Each therapeutic session lasts 30 minutes, with the cathode electrode localized over the patient-specific epileptic focus to reduce cortical hyperexcitability.

Other names: Brain Noninvasive Electrical Stimulation, tDCS, Placebo

Primary outcomes

  1. Weekly Seizure Frequency

    Time frame: Baseline and Week 24

    Assessment of patient-reported quality of life. The total score ranges from 0 to 100 points, where higher scores indicate a better quality of life. This scale will be evaluated as a single independent outcome measure. BaselineF LIFE IN EPILEPSY - QOLIE-31.

  2. Heart Rate Variability (HRV) Changes

    Time frame: Baseline and Week 24

    To evaluate cardiac safety, specific parameters will be extracted and analyzed from standard 12-lead ECG recordings. The assessed components will explicitly include: Heart Rate (bpm), PR interval (ms), QRS complex duration (ms), QT interval (ms), and corrected QT interval (QTc, ms) using Fridericia's formula

  3. Change from Baseline in Seizure Frequency

    Time frame: Baseline and Week 24

    Evaluation of efficacy based on the change in seizure frequency. This metric will assess the number of observable seizures per 28-day period (seizures/28 days), as documented by patient/caregiver diaries, comparing the baseline phase to the final 4 weeks of the treatment period (up to Week 24).

  4. Change from Baseline in Vital Signs

    Time frame: Baseline and Week 24

    Evaluation of clinical safety through the assessment of vital signs. The specific metrics to be evaluated independently as continuous variables include: Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Heart Rate (beats per minute), and Body Temperature (°C).

Secondary outcomes

  1. Change in Brain Electrical Activity via Electroencephalogram (EEG)

    Time frame: Baseline and Week 24

    Neurophysiological changes and treatment efficacy will be quantified using quantitative EEG (qEEG) analysis. The evaluation will precisely assess changes in absolute and relative power spectral density across the following frequency bandwidths: Delta (0.5-4 Hz), Theta (4-8 Hz), Alpha (8-12 Hz), and Beta (12-30 Hz). Additionally, the hourly frequency of epileptiform discharges (spikes and sharp waves) will be quantified to assess seizure susceptibility.

Other outcomes

  1. Kessler Foundation Neglect Assessment Process

    Time frame: 4 Months

    During each assessment session, occupational therapists measured patients' functions with the KF-NAP, Functional Independence Measure (FIM™) and Barthel Index (BI)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Spanish Foundation for Neurometrics Development

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 24, 2023
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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