Atlas of Intracranial Recordings on Cortical Responses After Functional tACS

Phase 1

• Conditions: Transcranial Alternating Current Stimulation
• Interventions: Device: tACS

• Registration Number: NCT04560959
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

By analyzing the SEEG recordings, we explore the range of cortical functional responses to strings of 77.5Hz stimulations delivered by tACS,

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-09-17
• Last Update Submitted: 2020-09-17
• Study Start: 2020-09-20
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23
• Primary Completion: 2021-05-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All epileptic patients that would receive the implantation of SEEG electrodes, regardless of the seizure locations;
• There was no metal implantation before;
• Eligible for MRI examination;
• No other lesional neurological disorders;
• Could be well informed by the study protocols.

Exclusion Criteria

• Suffered from any other mental illnesses prior to the enrollment;
• Those suffering from the serious or unstable organic diseases;
• Pregnant or lactation women, and those who have a plan of pregnant;
• Patients with central nervous system tumors, acute brain injury or infection;
• Skin injured, or allergic to the exposure of the conductive gel;
• Those with implanted devices;
• Those who received modified electrical convulsive therapy, or TMS within the recent one month;
• The score of item 3 (suicidal item) in HAMD-17 equal or greater than 3;
• Enrolled in any other on going trials;
• Other situations evaluated by the researchers as inappropriate to the enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tACS arm	tACS	The patient would receive strings of tACS stimulations in 77.5 HZ, each string would last for 1 second, followed by an interval of 5 seconds. A total of 600 strings would be sent out to the patients.

Primary Outcome Measures

Name	Time	Method
Changes of intracranial activities	Within 250 ms immediately after the stimulation.	The change of the power in a band of 0-200 HZ according to the intracranial EEG recording.

Secondary Outcome Measures

Name	Time	Method
Frequency of the epileptic discharges	50 minutes during the stimulation and 50 minutes of the interictal baseline before the intervention during the same hour of the day	To count the numbers of epileptic discharges within the same duration before and when tACS intervention.
Event related potential (ERP)	Baseline: 24 hours before the tACS intervention; Observation: Immediately after the end of the tACS intervention.	ERP related to cognitive tasks before and immediately after the tACS intervention