ClinicalTrials.gov
ClinicalTrials.gov Menu

High Definition Cathodal Transcranial Direct Current Stimulation for Treatment of Refractory Partial Onset Epilepsy (HD-TDCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02264652
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
Boston Children’s Hospital
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:

High-Definition transcranial Direct Current Stimulation (HD tDCS)

Genuine cathodal HD-tDCS will be delivered through High-Definition electrodes that will be arranged on the skull according to a 4x1-ring configuration with the central cathodal electrode placed over the identified target and surrounding return electrodes forming approximately a 5-cm radius ring.

Aim: To explore whether a novel form of tDCS can be a safe noninvasive treatment that could potentially suppress seizures in refractory partial-onset epilepsy.


Condition or disease Intervention/treatment Phase
Epilepsy Device: HD Transcranial Direct Stimulation Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Definition Cathodal Transcranial Direct Current Stimulation for Treatment of Refractory Partial Onset Epilepsy
Actual Study Start Date : August 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: HD Transcranial Direct Stimulation
Genuine cathodal HD-tDCS approximately 2mA will be delivered through High-Definition electrodes that will be arranged on the skull according to a 4x1-ring configuration with the central cathodal electrode placed over the identified target and surrounding return electrodes forming approximately a 5-cm radius ring.
Device: HD Transcranial Direct Stimulation
Genuine cathodal HD-tDCS will be delivered through High Definition electrodes that will be arranged on the skull according to a 4x1 ring configuration.
Other Name: HD-tDCS




Primary Outcome Measures :
  1. EEG monitoring [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 9 to 65 years
  2. Focal-onset neocortical epilepsy (as determined by semiology, EEG, and/or MRI)
  3. Frequent (>50% of EEG record) focal epileptiform discharges on EEG and/or frequent (defined as average of ≥2 daily seizures) focal-onset clinical seizure, refractory to medical anti-epileptic treatment. For the purposes of this study, any patient who has been treated with three or more AEDs at therapeutic doses for at least four weeks per drug will be considered medically refractory.
  4. Seizure onset must be localizable by clinical semiology, EEG or MRI.
  5. Subjects or guardians must be competent to sign an informed consent indicating awareness of the investigational nature of this study, treatment, benefits and procedures involved.

Exclusion Criteria:

  1. Age over 65 years or under 9 years.
  2. Implanted cardiac pacemakers, cochlear implants, implanted medication pump, or intracardiac line.
  3. Within past six months, history of active heart disease, stroke, respiratory disease, or increased intracranial pressure such as after infarction or trauma.
  4. Pregnant women. A urine test will be conducted on all post-menarchal females of childbearing age and potential to verify they are not pregnant.
  5. History of significant head trauma (loss of consciousness >10 minutes) within the past 6 months.
  6. Currently taking tricyclic anti-depressants, bupropion, or neuroleptic medications.
  7. Intracranial metal (e.g., cortical stimulator, deep brain stimulator, intraventricular catheter) within 4 cm of optimal stimulation site. Location of cranial metal (e.g. skull screws) should be carefully documented.
  8. Neurodegenerative disease.
  9. Radiographic or electrophysiologic evidence for deep structure seizure focus (e.g., mesial temporal sclerosis or periventricular heterotopia)
  10. Inability to remain seated and relatively still for 30 minutes.
  11. Benign rolandic epilepsy.

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): NCT02264652


Locations
United States, Massachusetts
Boston Children's Hospital - Neurology
Boston, Massachusetts, United States, 02115
United States, New York
Neurology
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Boston Children’s Hospital
Investigators
Principal Investigator: Anli Liu, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02264652     History of Changes
Other Study ID Numbers: 14-00622
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by New York University School of Medicine:
Refractory
Partial
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases