Ohtahara SyndromeNCT02960347
Examining the Efficacy of tDCS in the Attenuation of Epileptic Paroxysmal Discharges and Clinical Seizures
A study testing High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor in people with Ohtahara Syndrome, run by Herzog Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 10 to 36 months, men only
- Conditions the study is for
- Ohtahara Syndrome
- What is being tested?
- High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 36 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ohtahara Syndrome
- Being tested
- High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor
- Medical subject headings
- Infantile Epileptic-Dyskinetic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptorDevice
Also called tDCS
Non-invasive focal neuromodulation
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | open label active tDCS treatment Receives: Device: High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in seizure frequency from baseline
Measured: day 1, day 3, day 5, day 6, day 8, day 10, day 13, day 20, day 27, day 33, day 40, day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ohtahara SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herzog Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The City College of New York
- Responsible party
- Sponsor
- Investigators
- Rena Gale, MD, Principal investigator, Herzog Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960347
- Sponsor's protocol ID
- Meiron 2013-4
- Status last verified
- Nov 2016
- First submitted
- 1 Nov 2016
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27199889Sunderam 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.
PubMed 19926525Kessler 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.
PubMed 24086698Yook 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.
PubMed 22506177Datta 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.
PubMed 20648973Meiron 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.
PubMed 31191235
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of tDCS in the Attenuation of Epileptic Paroxysmal Discharges and Clinical Seizures
- ClinicalTrials.gov ID
- NCT02960347
- Acronym / sponsor ID
- Meiron 2013-4
- Conditions
- Ohtahara Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Herzog HospitalUniversity, hospital or other
- Collaborators
- The City College of New York
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptoropen label active tDCS treatment |
Who may qualify
- Ages
- 10 to 36 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptorAlso: tDCSNon-invasive focal neuromodulation | Device | Active tDCS |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Results publication: PubMed 27199889Auvichayapat 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 publication: PubMed 19926525Sunderam 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 publication: PubMed 24086698Kessler 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 publication: PubMed 22506177Yook 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 publication: PubMed 20648973Datta 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.
- Derived from this study: PubMed 31191235Meiron 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rena Gale, MD principal investigator
Herzog Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor in people with Ohtahara Syndrome, run by Herzog Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02960347, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.