Using tDCS stimulation to treat refractory status epilepticus
Application of Targeting Transcranial Direct Current Stimulation (tDCS) Stimulation in the Treatment of Refractory Status Epilepticus
This study is testing if a new brain stimulation treatment can help people with severe epilepsy that doesn't respond to regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06344338 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in patients suffering from refractory status epilepticus, a severe form of epilepsy that does not respond to standard treatments. Eligible participants will be randomly assigned to receive either active tDCS stimulation or a sham stimulation for up to ten sessions. The study will monitor the patients' responses to the treatment and assess any potential side effects. The goal is to determine if tDCS can effectively control seizures in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 to 80 who have been diagnosed with refractory status epilepticus and can undergo EEG monitoring.
Not a fit: Patients with unstable vital signs, severe skull injuries, or those with implanted electronic devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with refractory status epilepticus who currently have limited alternatives.
How similar studies have performed: While the use of tDCS in epilepsy is an emerging field, similar studies have shown promising results, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 14 and 80 year-old with Gender unlimited, * Suitable for EEG monitoring; * Clinical diagnosis of Refractory status epilepticus (status epilepticus that cannot be controlled by two types of antiepileptic drugs and at least one anesthetic); * Informed consent to participate in this study was obtained from the participants or their surrogates Exclusion Criteria: * Unstable vital signs (systolic blood pressure\<90mmHg, heart rate\<60 beats/min, pulse oxygen saturation\<90%); * Having severe skull injury/defect or medical equipment implanted in the head; * Pregnancy; * With any implantable electronic instrument (including pacemakers, vagus nerve stimulators) or metal implanted devices.
Where this trial is running
Beijing, Beijing Municipality
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jiaqing Yan, Dr — College of Electrical and Control Engineering, North China University of Technology
- Study coordinator: research centre of Xuanwu hospital Capital Medical University
- Email: liugangqingyi@sina.com
- Phone: +8601083198899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.