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

NCT ID: NCT02960347

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ohtahara Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active tDCS

open label active tDCS treatment

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Non-invasive focal neuromodulation

Interventions

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

Non-invasive focal neuromodulation

Intervention Type DEVICE

Other Intervention Names

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tDCS

Eligibility Criteria

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Inclusion Criteria

1. Initial diagnosis of Ohtahara syndrome/West syndrome/ Lennox-Gastaut syndrome by a pediatric neurologist using video-EEG
2. Ongoing synchronous Hypsarrhythmia
3. Modified Hypsarrhythmia with a consistent focus of paroxysmal discharges
4. Signed informed consent of parents/immediate legal guardian
5. Age 10 to 36 months
6. 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

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

10 Months

Maximum Eligible Age

36 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The City College of New York

OTHER

Sponsor Role collaborator

Herzog Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rena Gale, MD

Role: PRINCIPAL_INVESTIGATOR

Herzog Hospital

Locations

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Herzog Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type RESULT
PMID: 27199889 (View on PubMed)

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.

Reference Type RESULT
PMID: 19926525 (View on PubMed)

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.

Reference Type RESULT
PMID: 24086698 (View on PubMed)

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.

Reference Type RESULT
PMID: 22506177 (View on PubMed)

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.

Reference Type RESULT
PMID: 20648973 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31191235 (View on PubMed)

Other Identifiers

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Meiron 2013-4

Identifier Type: -

Identifier Source: org_study_id

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