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

Ohtahara Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960347
• Other study ID #: Meiron 2013-4
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Herzog Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 10 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Ohtahara Syndrome
• Seizures

Intervention

Device:
• High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor
Non-invasive focal neuromodulation

Locations

Country	Name	City	State
Israel	Herzog Hospital	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Herzog Hospital	The City College of New York

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. eColle — View 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. — View 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 2 — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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