Transcranial Electrical Neuromodulation for Suppressing Epileptiform Discharges

Stopped early · Not applicable

Conditions studied: Epilepsy

In brief

This study examines the safety and feasibility of suppressing epileptic discharges through inducing long term depression of the epileptic focus with transcranial electrical neuromodulation.

Key facts

Study ID

NCT02516228

Run by

Electrical Geodesics, Inc.

People needed

6

Starts

2016-08-01

Expected to finish

2018-05-01

Last updated by the study team

2020-07-22

Who can join

Age: 14 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 14 to 60.
• Partial onset seizures (simple or complex) with failure of adequate seizure control after prior use of at least 2 anti-seizure drugs at effective doses.
• Only one clearly identified and localizable extratemporal focus of epileptiform discharges, as defined the discharges (typically epileptiform spikes) and as identified by dEEG assessment through one or more routine clinical dEEG evaluations.
• Two or more partial seizures, with or without secondary generalization, in the last month, but less than 10 seizures per day.
• Anti-seizure drug regimen has remained unchanged for the month before study entry, and there is reasonable likelihood of stability for the duration of the study, with the exception of allowing short-term rescue medications, such as lorazepam.
• A history of epilepsy for at least 2 years.

You may not qualify if…

• Patient is pregnant or becomes pregnant
• A history or condition of progressive brain disorders, unstable systemic diseases, symptomatic cerebrovascular disease, cardiac disease, or alcohol/substance abuse.Special conditions, for example, non-malignant brain tumors and vascular malformations, can be considered for entry on a case-by-case basis.
• A history or condition of status epilepticus or psychogenic seizures (seizures not confirmed by EEG).
• Presence of a cardiac pacemaker, vagus nerve stimulator, or metal implants in the body (other than the teeth) including neurostimulators, cochlear implants, and implanted medication pumps (screened using the LCNI Safety Screening Questionaire).
• Previous surgery involving opening the skull.
• Allergy to or condition contraindicating lidocaine.
• Unable to express presence of pain or discomfort.
• Allergy to silver
• Participating in other competing clinical trials
• Unable to speak English
• Unable to knowingly give consent

Where it is running

• Harborview Medical Center - University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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