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NCT Number: NCT06344338

Application of tDCS Stimulation in Controlling Refractory Status Epilepticus

The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus

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Key information

Conditions

Refractory Status Epilepticus Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Status Epilepticus

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Weibi Chen

CONTACT

[email protected]

+8615010255903

About this study

After being informed about the study and potential risks, the recruited patients, giving written informed consent, will be determined of the eligibility for study entry. The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tDCS stimulation

Device

In the real-stimulation group, Treatment was for 20 min, repeated twice in a day, then again over the next few days. The maximum number of stimuli required to terminate the status epilepticus should not exceed 10. In the sham-stimulation group, The duration and frequency of tDCS are the same as those in the treatment group, but the tDCS device is not active during the 20 minutes of sham-stimulation

TDCS sham-stimulation

Device

TDCS sham-stimulation

Primary outcomes

  1. Number of participants with status epilepticus termination between tDCS treatment group and tDCS sham--stimulation group as assessed by Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus

    Time frame: through study completion, an average of 1 year

    Outcomes will be assessed by clinical observation and EEG evaluation before 10 times of tDCS stimulation between both groups

Secondary outcomes

  1. Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group

    Time frame: through study completion, an average of 1 year

    Treatment-emergent adverse events will be assessed by clinical observation between tDCS treatment group and tDCS sham--stimulation group

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaqing Tian, Dr

CONTACT

[email protected]

+8615311415116

research centre of Xuanwu hospital Capital Medical University

CONTACT

[email protected]

+8601083198899 ext. 8270

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Application of Targeting Transcranial Direct Current Stimulation (tDCS) Stimulation in the Treatment of Refractory Status Epilepticus

Acronym: tDCS

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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