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

Primary Purpose

Ohtahara Syndrome

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Ohtahara Syndrome

Eligibility Criteria

10 Months - 36 Months (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

Herzog Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active tDCS

Arm Description

open label active tDCS treatment

Outcomes

Primary Outcome Measures

change in seizure frequency from baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT02960347

First Posted

November 1, 2016

Last Updated

August 3, 2022

Sponsor

Herzog Hospital

Collaborators

The City College of New York

1. Study Identification

Unique Protocol Identification Number

NCT02960347

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Herzog Hospital

Collaborators

The City College of New York

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ohtahara Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS

Arm Type

Experimental

Arm Description

open label active tDCS treatment

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

tDCS

Intervention Description

Non-invasive focal neuromodulation

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

10 Months

Maximum Age & Unit of Time

36 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rena Gale, MD

Organizational Affiliation

Herzog Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herzog Hospital

City

Jerusalem

ZIP/Postal Code

9103702

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27199889

Citation

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.

Results Reference

result

PubMed Identifier

19926525

Citation

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.

Results Reference

result

PubMed Identifier

24086698

Citation

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.

Results Reference

result

PubMed Identifier

22506177

Citation

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.

Results Reference

result

PubMed Identifier

20648973

Citation

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.

Results Reference

result

PubMed Identifier

31191235

Citation

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.

Results Reference

derived

Learn more about this trial

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

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