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Trial record 20 of 27 for:    "X-linked infantile spasm syndrome"

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

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ClinicalTrials.gov Identifier: NCT02960347
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
The City College of New York
Information provided by (Responsible Party):
Herzog Hospital

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.

Condition or disease Intervention/treatment Phase
Ohtahara Syndrome Device: High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Examining the Efficacy of tDCS in the Attenuation of Epileptic Paroxysmal Discharges and Clinical Seizures
Study Start Date : February 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: Active tDCS
open label active tDCS treatment
Device: High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor
Non-invasive focal neuromodulation
Other Name: tDCS




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   10 Months to 36 Months   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960347


Locations
Israel
Herzog Hospital
Jerusalem, Israel, 9103702
Sponsors and Collaborators
Herzog Hospital
The City College of New York
Investigators
Principal Investigator: Rena Gale, MD Herzog Hospital

Publications of Results:
Responsible Party: Herzog Hospital
ClinicalTrials.gov Identifier: NCT02960347     History of Changes
Other Study ID Numbers: Meiron 2013-4
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms