TDCs to Treat Drug-resistant Epilepsy

NCT05825274 | Completed DMC

• 1 other identifier: RefEpTDCs
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Forms of Epilepsy, Treatment Resistant

Keywords

Drug-resistant epilepsy; tDCS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Quality live improve

  4 months

• Kessler Foundation Neglect Assessment Process

  4 Months

Study Arms (2)

Refractory Epilepsy Group

EXPERIMENTAL

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

Placebo Patients

PLACEBO COMPARATOR

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

Interventions

Cathodal tDCS DEVICE

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

Also known as: Brain Noninvasive Electrical Stimulation, tDCS

Placebo Patients; Refractory Epilepsy Group

Eligibility Criteria

• Age: 18 Months - 120 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Foundation for Neurometrics Development: lead

Study Sites (1)

New Remedies Ltd

Liverpool, Merseyside, L1 0AH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 21885255 RESULT

• 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.

  PMID: 29312132 RESULT

• Engel J Jr. Approaches to refractory epilepsy. Ann Indian Acad Neurol. 2014 Mar;17(Suppl 1):S12-7. doi: 10.4103/0972-2327.128644.

  PMID: 24791078 RESULT

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jean Neville, MD

  New Remedies Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: we use in half of patient cathodal tDCS or Brain noninvasive stimulation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Spanish Foundation for Neurometrics Development

Model Details: Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: April 24, 2023
• Study Start: January 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: December 28, 2017
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: 4 Months
• Access Criteria: login and password previous registration in neuroterapias.es

Locations

GB (1)