High Definition Cathodal Transcranial Direct Current Stimulation for Treatment of Refractory Partial Onset Epilepsy

NCT02264652 | Completed Phase 1 DMC

• 1 other identifier: 14-00622
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy

Keywords

Refractory; Partial; Epilepsy

Outcome Measures

Primary Outcomes (1)

• EEG monitoring

  30 minutes

Study Arms (1)

HD Transcranial Direct Stimulation

EXPERIMENTAL

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

Interventions

HD Transcranial Direct Stimulation DEVICE

Genuine cathodal HD-tDCS will be delivered through High Definition electrodes that will be arranged on the skull according to a 4x1 ring configuration.

Also known as: HD-tDCS

HD Transcranial Direct Stimulation

Eligibility Criteria

• Age: 9 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 9 to 65 years
• Focal-onset neocortical epilepsy (as determined by semiology, EEG, and/or MRI)
• 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.
• Seizure onset must be localizable by clinical semiology, EEG or MRI.
• 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.

You may not qualify if:

• Age over 65 years or under 9 years.
• Implanted cardiac pacemakers, cochlear implants, implanted medication pump, or intracardiac line.
• Within past six months, history of active heart disease, stroke, respiratory disease, or increased intracranial pressure such as after infarction or trauma.
• Pregnant women. A urine test will be conducted on all post-menarchal females of childbearing age and potential to verify they are not pregnant.
• History of significant head trauma (loss of consciousness \>10 minutes) within the past 6 months.
• Currently taking tricyclic anti-depressants, bupropion, or neuroleptic medications.
• 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.
• Neurodegenerative disease.
• Radiographic or electrophysiologic evidence for deep structure seizure focus (e.g., mesial temporal sclerosis or periventricular heterotopia)
• Inability to remain seated and relatively still for 30 minutes.
• Benign rolandic epilepsy.

Sponsors & Collaborators

• NYU Langone Health: lead
• Boston Children's Hospital: collaborator

Study Sites (2)

Boston Children's Hospital - Neurology

Boston, Massachusetts, 02115, United States

Location

Neurology

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anli Liu, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 15, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

US (2)