Transcranial direct current stimulation for focal status epilepticus or lateralized periodic discharges in four patients in a critical care setting.
Robert S Fisher, Ryan J McGinn, Erica L Von Stein...
https://pubmed.ncbi.nlm.nih.gov/36661376Actively Recruiting
Phase Not Applicable
Age: 14Years - 80Years
All Genders
ID06344338
Application of Targeting Transcranial Direct Current Stimulation (tDCS) in the Treatment of Refractory Status Epilepticus
Led by Xuanwu Hospital, Beijing · Updated on 2024-07-31
32
Participants Needed
1
Research Sites
12 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the use of targeted transcranial direct current stimulation (tDCS) to treat refractory status epilepticus, a condition where seizures persist despite treatment with multiple antiepileptic drugs and anesthetics. The study aims to assess both the effectiveness and safety of this approach by comparing active tDCS stimulation to a sham (inactive) stimulation. This interventional trial is sponsored by Xuanwu Hospital, Beijing. Participants are randomly assigned to one of two groups. The active tDCS group receives cathodal current at 2 mA over the seizure onset zone for 20 minutes, twice a day, repeated over several days, but not exceeding 10 sessions. The sham group undergoes the same schedule and duration of treatment, but the device is not active during sessions. This design allows comparison between real and sham stimulation effects. During the study, participants will be monitored using EEG and assessed for seizure termination based on the Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus. Researchers will also track any treatment-related adverse events throughout the study, which lasts about one year from treatment start. This includes safety follow-up and outcome evaluations to better understand the potential benefits and risks of targeted tDCS for this severe seizure condition.
CONDITIONS
Brief Title
Application of tDCS Stimulation in Controlling Refractory Status Epilepticus
Who Can Participate
Age: 14Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 14 and 80 years, any gender
- Suitable for EEG monitoring
- Clinical diagnosis of refractory status epilepticus not controlled by two types of antiepileptic drugs and at least one anesthetic
- Informed consent obtained from participant or surrogate
You will not qualify if you...
- Unstable vital signs (systolic blood pressure below 90 mmHg, heart rate below 60 beats per minute, oxygen saturation below 90%)
- Severe skull injury or defect, or medical equipment implanted in the head
- Pregnancy
- Any implanted electronic device (such as pacemakers or vagus nerve stimulators) or metal implants in the head
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to the time required to complete a maximum of 10 stimuli sessions
Participants receive up to 10 sessions of transcranial direct current stimulation (tDCS) or sham stimulation to control refractory status epilepticus. Each session lasts 20 minutes and is repeated twice daily over several days.
Up to 10 treatment sessions, with 2 sessions per day
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
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Research Team
R
research centre of Xuanwu hospital Capital Medical University
J
Jiaqing Tian, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Therapeutic efficacy of seizure onset zone-targeting high-definition cathodal tDCS in patients with drug-resistant focal epilepsy.
Soheila Rezakhani, Mahmood Amiri, Sarah Weckhuysen...
https://pubmed.ncbi.nlm.nih.gov/35217351