← Back to Search

tDCS for Refractory Status Epilepticus

N/A

Recruiting

Led By Imran Quraishi, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A patient with SRSE is defined as requiring at least 24 hours of a third-line intravenous anesthetic therapy (IVAT) such as propofol, midazolam, or ketamine, and failing at least one previous wean of an IVAT.

A patient with RSE is defined as having seizure(s) refractory to first line benzodiazepines and second-line antiseizure medications (ASMs; phenytoin, levetiracetam, valproate).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial studies the use of a non-invasive, easily administered therapy, transcranial direct current stimulation, to reduce seizure burden in patients with refractory seizures or abnormal brain wave patterns.

Who is the study for?

This trial is for patients with severe, ongoing seizures not controlled by standard medications. They must have access to continuous EEG monitoring and brain imaging within the last year. It's not suitable for pregnant individuals, those with scalp issues affecting EEG readings, or people with certain metal implants or devices in their body.Check my eligibility

What is being tested?

Researchers are testing transcranial direct current stimulation (tDCS) as an additional treatment for refractory status epilepticus. The study will randomly assign participants to receive either tDCS or a sham stimulation to see if it influences their brain wave patterns.See study design

What are the potential side effects?

Potential side effects of tDCS may include discomfort at the site of electrode placement, itching, tingling, headache, fatigue and in rare cases could cause skin irritation or burns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had severe seizures requiring strong IV medication for over 24 hours and failed at least one attempt to reduce the medication.

Select...

My seizures did not stop with first and second-line seizure medications.

Select...

My seizures haven't stopped with initial treatments and last over an hour.

Select...

I have severe, ongoing seizures not responding to treatment for over 12 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recruitment capability of the study site- Incidence

Recruitment capability of the study site- Percent Consent

Recruitment capability of the study site- Percent Eligible

+2 more

Secondary outcome measures

Ability to implement protocol at study site

Ability to implement protocol at study site- Device Failures

Ability to implement protocol at study site- Participants Lost to Follow Up

+9 more

Side effects data

From 2021 Phase 2 & 3 trial • 160 Patients • NCT02483468

Car accident

skin irritation

100%

80%

60%

40%

20%

Study treatment Arm

tDCS (Active)

tDCS (Sham)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: StimulationExperimental Treatment1 Intervention

The tDCS device will stimulate with a 2mA current during sessions. Both arms receive application of the device for 3 sessions of 2x 30 minute active application with 30 minutes rest in between.

Group II: Sham StimulationPlacebo Group1 Intervention

The tDCS device will stimulate with a 0mA current during sessions (sham). Both arms receive application of the device for 3 sessions of 2x 30 minute active application with 30 minutes rest in between.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Direct Current Stimulation

2014

Completed Phase 3

~1100

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,501 Total Patients Enrolled

Imran Quraishi, MD, PhDPrincipal InvestigatorYale University

Media Library

Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT05934903 — N/A

Epileptic Seizure Research Study Groups: Stimulation, Sham Stimulation

Epileptic Seizure Clinical Trial 2023: Stimulation Highlights & Side Effects. Trial Name: NCT05934903 — N/A

Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05934903 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this research endeavor benefit from additional participants?

"As per the records on clinicaltrials.gov, this endeavour is not currently enrolling patients. It was first published August 1st 2023 and last updated June 28th 2023, but 19 other trials are presently recruiting individuals."

Answered by AI

What is the fundamental aim of this experimentation?

"The primary outcome of this trial, which will be monitored for up to two years, is the recruitment rate at each study site. Additionally, other metrics such as protocol deviations including un-blinding and contamination; participant follow-up; and device failures in comparison to total number of stimulation sessions shall also be measured."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus

2023. "Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05934903.