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OpenTrials
Completed

NCT Number: NCT05825274

TDCs to Treat Drug-resistant Epilepsy

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.

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Key information

Age range

18 month–120 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Remedies Ltd

Liverpool, Merseyside, L1 0AH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Cathodal tDCS

Device

We do 2 sessions per week of 35 minutes with cathodal electrodes over epileptic focus

Other names: Brain Noninvasive Electrical Stimulation, tDCS

Primary outcomes

  1. Decrease in number of crisis per day

    Time frame: 4 months

    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

  2. Body mass index

    Time frame: 4 Months

    kg / m^2

Secondary outcomes

  1. Quality live improve

    Time frame: 4 months

    less drugs consum and number of crisis per week, or moderate changes in EEG or brainwaves

  2. 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)

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
May 8, 2024

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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