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Completed

NCT Number: NCT02960347

Examining the Efficacy of tDCS in the Attenuation of Epileptic Paroxysmal Discharges and Clinical Seizures

The current study examined the feasibility of High-Definition tDCS (HD-tDCS) in reducing epileptiform activity in a 30-month-old child suffering from early onset epileptic encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks including pre- and post-intervention video-electroencephalography (EEG) monitoring.

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Key information

Conditions

Ohtahara Syndrome Infantile Epileptic-Dyskinetic Encephalopathy

Age range

10 month–36 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Herzog Hospital

Jerusalem, 9103702, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Initial diagnosis of Ohtahara syndrome/West syndrome/ Lennox-Gastaut syndrome by a pediatric neurologist using video-EEG
  • Ongoing synchronous Hypsarrhythmia
  • Modified Hypsarrhythmia with a consistent focus of paroxysmal discharges
  • Signed informed consent of parents/immediate legal guardian
  • Age 10 to 36 months
  • Infant should be in a steady state indicated by a baseline test of electrolytes and biochemistry blood test, heart rate, temperature, respiratory rate, and saturation.

Exclusion criteria

  • Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  • History of adverse reaction to neurostimulation
  • Significant ECG abnormality

Treatment and study plan

High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor

Device

Non-invasive focal neuromodulation

Other names: tDCS

Primary outcomes

  1. change in seizure frequency from baseline

    Time frame: day 1, day 3, day 5, day 6, day 8, day 10, day 13, day 20, day 27, day 33, day 40, day 50

Sponsors and collaborators

Lead sponsor

Herzog Hospital

Other

Collaborators

  • The City College of New York

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 9, 2016
Registry last updated
Aug 5, 2022

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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