Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

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

FieldValue
Enrollment Target 190 participants
Start Date 2021-10-25
Est. Completion 2026-07
Phase NA

Sponsor

Neuroelectrics Corporation

2 total trials

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.

Similar trials for Epilepsy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.