Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT05934903
Status:
TERMINATED
Last Update Posted:
2025-04-04
First Post:
2023-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Feasibility Study: tDCS for Treatment of Refractory Status Epilepticus
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to meet adequate enrolment numbers for feasibility.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
This is study is designed to determine the feasibility of implementing a double-blinded tDCS in inpatients with status epilepticus and other abnormal EEG (electroencephalography) patterns. The study includes assessments of recruitment capability, the ability to implement the study procedures, the safety profile, and preliminary evaluation of participant response to transcranial direct current stimulation (tDCS) therapy, to see which clinical outcome measures are most practical.
Patients who are admitted to Yale New Haven Hospital with refractory status epilepticus or EEG patterns falling on the ictal-interictal continuum (IIC, rhythmic or periodic patterns with rates more than 1Hz and less than or equal to 2.5Hz) will be recruited, starting from August 1st 2023 until July 31st 2025, or until 60 total participants, whichever is sooner. Those who are eligible will be randomized into two groups: stimulation or sham, all while receiving standard of care according to their primary teams.
Each subject will receive up to 3 sessions of tDCS over a 72 hour period with at least 24 hours between each session. Each session will consist of 30 minutes of stimulation (or sham), a 30 minute break and a second 30 minute of stimulation (or sham). Stimulation will be applied using the ActivaDose II device (Caputron). Saline soaked sponges will be prepared, with the cathode being placed on the area corresponding to the seizure focus or point of maximal epileptic potential as defined on the international 10-20 EEG system. The anode will be placed on the contralateral shoulder. During each session, a maximum of total injected current across the electrodes of 2mA will be used, as conventional tDCS with 2mA is well-tolerated in adults and children. Sham stimulation includes application of the electrodes and timing the device to deliver 0mA of injected current.
The patients will not be aware of their randomization arm. The research staff analyzing the EEG data will not be aware of the patient's treatment arm.
The study schedule will include:
1. Screening and Consent visit
2. Stimulation Sessions - 3 one-hour stimulation sessions, distributed over 72 consecutive hours, and no less than 24 hours apart.
3. Follow up visit at 30 days after intervention.
Patients who are admitted to Yale New Haven Hospital with refractory status epilepticus or EEG patterns falling on the ictal-interictal continuum (IIC, rhythmic or periodic patterns with rates more than 1Hz and less than or equal to 2.5Hz) will be recruited, starting from August 1st 2023 until July 31st 2025, or until 60 total participants, whichever is sooner. Those who are eligible will be randomized into two groups: stimulation or sham, all while receiving standard of care according to their primary teams.
Each subject will receive up to 3 sessions of tDCS over a 72 hour period with at least 24 hours between each session. Each session will consist of 30 minutes of stimulation (or sham), a 30 minute break and a second 30 minute of stimulation (or sham). Stimulation will be applied using the ActivaDose II device (Caputron). Saline soaked sponges will be prepared, with the cathode being placed on the area corresponding to the seizure focus or point of maximal epileptic potential as defined on the international 10-20 EEG system. The anode will be placed on the contralateral shoulder. During each session, a maximum of total injected current across the electrodes of 2mA will be used, as conventional tDCS with 2mA is well-tolerated in adults and children. Sham stimulation includes application of the electrodes and timing the device to deliver 0mA of injected current.
The patients will not be aware of their randomization arm. The research staff analyzing the EEG data will not be aware of the patient's treatment arm.
The study schedule will include:
1. Screening and Consent visit
2. Stimulation Sessions - 3 one-hour stimulation sessions, distributed over 72 consecutive hours, and no less than 24 hours apart.
3. Follow up visit at 30 days after intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| No NIH funding | OTHER | 10.11.23 | View |