Clinical trial NCT02960347: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ohtahara Syndrome
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
Collaborators: name: The City College of New York
First posted: 2016-11-09
Enrollment: 1
Sex: MALE
Minimum age (years): 10
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in seizure frequency from baseline
timeFrame: 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:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Herzog Hospital
Study officials:
affiliation: Herzog Hospital
name: Rena Gale, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.