NCT02960347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
Last Updated

August 5, 2022

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

November 1, 2016

Last Update Submit

August 3, 2022

Conditions

Ohtahara Syndrome

Outcome Measures

Primary Outcomes (1)

  • change in seizure frequency from baseline

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

Study Arms (1)

Active tDCS

EXPERIMENTAL

open label active tDCS treatment

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

Interventions

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

Non-invasive focal neuromodulation

Also known as: tDCS
Active tDCS

Eligibility Criteria

Age10 Months - 36 Months
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzog Hospital

Jerusalem, 9103702, Israel

Location

Related Publications (6)

  • Auvichayapat N, Sinsupan K, Tunkamnerdthai O, Auvichayapat P. Transcranial Direct Current Stimulation for Treatment of Childhood Pharmacoresistant Lennox-Gastaut Syndrome: A Pilot Study. Front Neurol. 2016 May 4;7:66. doi: 10.3389/fneur.2016.00066. eCollection 2016.

    PMID: 27199889RESULT

  • Sunderam S, Gluckman B, Reato D, Bikson M. Toward rational design of electrical stimulation strategies for epilepsy control. Epilepsy Behav. 2010 Jan;17(1):6-22. doi: 10.1016/j.yebeh.2009.10.017. Epub 2009 Nov 17.

    PMID: 19926525RESULT

  • Kessler SK, Minhas P, Woods AJ, Rosen A, Gorman C, Bikson M. Dosage considerations for transcranial direct current stimulation in children: a computational modeling study. PLoS One. 2013 Sep 27;8(9):e76112. doi: 10.1371/journal.pone.0076112. eCollection 2013.

    PMID: 24086698RESULT

  • Yook SW, Park SH, Seo JH, Kim SJ, Ko MH. Suppression of seizure by cathodal transcranial direct current stimulation in an epileptic patient - a case report -. Ann Rehabil Med. 2011 Aug;35(4):579-82. doi: 10.5535/arm.2011.35.4.579. Epub 2011 Aug 31.

    PMID: 22506177RESULT

  • Datta A, Bansal V, Diaz J, Patel J, Reato D, Bikson M. Gyri-precise head model of transcranial direct current stimulation: improved spatial focality using a ring electrode versus conventional rectangular pad. Brain Stimul. 2009 Oct;2(4):201-7, 207.e1. doi: 10.1016/j.brs.2009.03.005.

    PMID: 20648973RESULT

  • Meiron O, Gale R, Namestnic J, Bennet-Back O, Gebodh N, Esmaeilpour Z, Mandzhiyev V, Bikson M. Antiepileptic Effects of a Novel Non-invasive Neuromodulation Treatment in a Subject With Early-Onset Epileptic Encephalopathy: Case Report With 20 Sessions of HD-tDCS Intervention. Front Neurosci. 2019 May 29;13:547. doi: 10.3389/fnins.2019.00547. eCollection 2019.

    PMID: 31191235DERIVED

MeSH Terms

Conditions

Infantile Epileptic-Dyskinetic Encephalopathy

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Rena Gale, MD

    Herzog Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 9, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

August 5, 2022

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)