- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02516228
Transcranial Electrical Neuromodulation for Suppressing Epileptiform Discharges (GTEN)
Geodesic Transcranial Electrical Neuromodulation(GTEN100) Device
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center - University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GTEN 100
All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Number of Spikes Per Hour
Time Frame: Baseline and following the 5 day treatment session
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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.
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Baseline and following the 5 day treatment session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Seizures
Time Frame: Baseline measurement and the Nine Month visit
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Weekly change in the number of seizures, assessed by the seizure diary in comparison to the mean weekly seizure frequency for the baseline evaluation period;
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Baseline measurement and the Nine Month visit
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Change in Cognitive Function Test Score
Time Frame: Nine months
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Change of cognitive function testing score beyond the practice effect (estimated from norms) ;
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Nine months
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Change in Quality of Life Rating
Time Frame: Nine months
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Change from baseline in quality of life rating
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Nine months
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Duration of Spike Count Suppression
Time Frame: Measured at baseline. treatment and at the 9 month followup visit
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• With assessments of spike rates after treatment session and at visits at weeks 2, 4, 8, 16, and 24, the duration of any suppression in spike rate can be explored.
All spike rates (baseline, treatment, and follow-up) will also be classified in relation to waking or sleep stage (N1, N2, N3).
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Measured at baseline. treatment and at the 9 month followup visit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Don M Tucker, Ph.D, C.E.O/, Chief Scientist
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGI-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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