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Clinical Trials/NCT02960347
NCT02960347CompletedNot Applicable

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

Herzog Hospital1 site in 1 country1 target enrollmentStarted: February 1, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1
Locations
1
Primary Endpoint
change in seizure frequency from baseline
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
10 Months to 36 Months (Child)
Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

Active tDCS

Experimental

open label active tDCS treatment

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Herzog Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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