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Transcranial Electrical Neuromodulation for Suppressing Epileptiform Discharges

NCT02516228 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-07-22

Study results available
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Summary

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

Conditions

Interventions

DEVICE

GTEN 100

Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day. During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days.

Sponsors & Collaborators

  • Harborview Injury Prevention and Research Center

    collaborator OTHER

  • Electrical Geodesics, Inc.

    lead INDUSTRY

Principal Investigators

  • Don M Tucker, Ph.D · C.E.O/, Chief Scientist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02516228 on ClinicalTrials.gov