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NCT04770337 · ClinicalTrials.gov registry record · NA
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
A NA study of Epilepsy and Seizures, sponsored by Neuroelectrics Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 190
- Enrollment target
- 20
- Study locations
NCT04770337 is a NA study of Epilepsy and Seizures that is actively recruiting participants, run by Neuroelectrics Corporation. The registered enrollment target is 190 participants, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT04770337, a NA study of Epilepsy and Seizures, is actively recruiting participants, sponsored by Neuroelectrics Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 190 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.
Conditions Studied
Interventions
- DEVICE STARSTIM device
- DEVICE Sham Device
Study Locations (20)
California
- Loma Linda University Health - Loma Linda
- Keck Medicine of USC - Los Angeles
- Children's Hospital of Orange County - Orange
Maryland
- Sinai Hospital - Baltimore
- Johns Hopkins University - Baltimore
Massachusetts
- Boston Children's Hospital Comprehensive Epilepsy Center - Boston
- Beth Israel Deconess Medical Center - Boston
Other
- Cliniques Universitaires Saint Luc - Brussels
- Ghent University Hospital - Ghent
Arizona
- Barrow Neurological Institute, St. Joseph's Hospital & Medical Center - Phoenix
Florida
- University of Florida Jacksonville - Jacksonville
Illinois
- Southern Illinois University School of Medicine - Springfield
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2026-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04770337
The ClinicalTrials.gov registry entry for NCT04770337 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (80% lower). The listed sponsor is Neuroelectrics Corporation, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which STARSTIM device is the first listed.
NCT04770337 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04770337 about?
NCT04770337 is a clinical study titled "Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy". This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will...
What is the current status of trial NCT04770337?
This trial is currently recruiting. It is a NA study. The enrollment target is 190 participants. The study started on 2021-10-25. Estimated completion is 2026-07.
What conditions does trial NCT04770337 study?
This clinical trial studies the following conditions: Epilepsy, Seizures, Epilepsy in Children, Refractory Epilepsy, Focal Seizure.
What interventions are being tested in trial NCT04770337?
The interventions under investigation include: STARSTIM device (DEVICE), Sham Device (DEVICE).
Who is sponsoring clinical trial NCT04770337?
This trial is sponsored by Neuroelectrics Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04770337 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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