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Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus

NCT05934903 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-04-04

No results posted yet for this study

Summary

Status epilepticus, or recurrent seizures without return to baseline, is a neurologic emergency. Refractory status epilepticus occurs when seizures are resistant to multiple first line anti-seizure medications. The ability to quickly stop seizures is paramount. Transcranial direct current simulation is a non-invasive, easily administered therapy that can potentially help reduce seizure burden.

The goal of this feasibility study is to assess the ability of the study site to enroll patients admitted with refractory seizures or those with abnormal brain wave patterns to take part in a study looking to use transcranial direct current stimulation as an adjunctive treatment. The main questions it aims to answer are:

* What is the recruitment capability of the study site?
* How well can the study site adhere to study protocol?
* Are there any adverse effects of using the transcranial direct current stimulation device?
* How do patients' brain wave studies respond to the stimulation? Participants will be asked to consider joining the study. Once joined, researchers will randomly assign participants to compare transcranial stimulation versus sham stimulation to see if this will affect the participant's brain wave patterns.

Conditions

  • Status Epilepticus
  • Refractory Status Epilepticus

Interventions

DEVICE

Transcranial Direct Current Stimulation

Cathodal direct current stimulation at 0 or 2mA will be applied to subjects

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Imran Quraishi, MD, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05934903 on ClinicalTrials.gov