Application of tDCS Stimulation in Controlling Refractory Status Epilepticus

NCT06344338 | Recruiting

• 1 other identifier: Z211100002921030
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractory Status Epilepticus

Outcome Measures

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

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

  through study completion, an average of 1 year

Secondary Outcomes (1)

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

  through study completion, an average of 1 year

Study Arms (2)

tDCS treatment group

EXPERIMENTAL

In the real tDCS stimulation group, direct cathodal current at 2 mA was delivered by a tDCS device over the seizure onset zone. Anode was on the contralateral forehead. 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.

Device: tDCS stimulation

TDCS sham-stimulation group

SHAM COMPARATOR

The duration and frequency of tDCS treatments in the sham-stimulation group are the same as those in the treatment group, but the tDCS device is not active during the 20 minutes of sham-stimulation.

Device: TDCS sham-stimulation

Interventions

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 treatment group

TDCS sham-stimulation DEVICE

TDCS sham-stimulation

TDCS sham-stimulation group

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (2)

• Fisher RS, McGinn RJ, Von Stein EL, Wu TQ, Qing KY, Fogarty A, Razavi B, Venkatasubramanian C. Transcranial direct current stimulation for focal status epilepticus or lateralized periodic discharges in four patients in a critical care setting. Epilepsia. 2023 Apr;64(4):875-887. doi: 10.1111/epi.17514. Epub 2023 Feb 7.

  PMID: 36661376 RESULT

• Rezakhani S, Amiri M, Weckhuysen S, Keliris GA. Therapeutic efficacy of seizure onset zone-targeting high-definition cathodal tDCS in patients with drug-resistant focal epilepsy. Clin Neurophysiol. 2022 Apr;136:219-227. doi: 10.1016/j.clinph.2022.01.130. Epub 2022 Feb 3.

  PMID: 35217351 RESULT

MeSH Terms

Conditions

Status Epilepticus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Weibi Chen, Dr

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

• Jiaqing Yan, Dr

  College of Electrical and Control Engineering, North China University of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

research centre of Xuanwu hospital Capital Medical University

CONTACT

+8601083198899; liugangqingyi@sina.com

Jiaqing Tian, Dr

CONTACT

+8615311415116; smile21tian@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: 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

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)