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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: Recruiting NA study of Epilepsy and Seizures, sponsored by Neuroelectrics Corporation.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Epilepsy Seizures Epilepsy in Children Refractory Epilepsy Focal Seizure Epilepsy, Tonic-Clonic Seizures, Focal

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
Neuroelectrics Corporation

2 total trials

What NCT04770337 shows while recruiting

NCT04770337 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (80% lower).

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 names 20 study sites across 15 states, led by 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.

Learn More About Clinical Trials

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.

Where NCT04770337's enrollment target sits among peer trials

190 34th of 160 higher than 126 of 160 other Epilepsy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04770337

Source: ClinicalTrials.gov NCT04770337, the US trial registry maintained by the National Library of Medicine. NCT04770337 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.