Transcranial Electrical Neuromodulation for Suppressing Epileptiform Discharges

NCT02516228 | Terminated Results DMC

• 1 other identifier: EGI-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Change in Number of Spikes Per Hour

  The main efficacy endpoint will be the change from baseline in number of spikes per hour (spike rate), as assessed with routine dEEG sessions, at each visit and after each treatment sessions.

  Baseline and following the 5 day treatment session

Secondary Outcomes (4)

• Change in Seizures

  Baseline measurement and the Nine Month visit

• Change in Cognitive Function Test Score

  Nine months

• Change in Quality of Life Rating

  Nine months

• Duration of Spike Count Suppression

  Measured at baseline. treatment and at the 9 month followup visit

Study Arms (1)

GTEN 100

EXPERIMENTAL

All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only.

Device: GTEN 100

Interventions

GTEN 100 DEVICE

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.

Also known as: GTEN

GTEN 100

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Electrical Geodesics, Inc.: lead
• Harborview Injury Prevention and Research Center: collaborator

Study Sites (1)

Harborview Medical Center - University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Sr. Clinical Operations Manager
• Organization: Philips

pat.olsen@philips.com

3034753417

Study Officials

• Don M Tucker, Ph.D

  C.E.O/, Chief Scientist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: August 5, 2015
• Study Start: August 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 22, 2020
• Results First Posted: July 22, 2020

Record last verified: 2019-10

Locations

US (1)