Atlas of Intracranial Recordings on Cortical Responses After Functional tACS

NCT ID: NCT04560959

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-20
• Study Completion Date: 2021-12-01

Brief Summary

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

Conditions

Transcranial Alternating Current Stimulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tACS arm

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.

Group Type: EXPERIMENTAL

tACS

Intervention Type: DEVICE

tACS would be performed to epilepsy patients who have already received implantation of the SEEG electrodes

Interventions

tACS

tACS would be performed to epilepsy patients who have already received implantation of the SEEG electrodes

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

G.G. Zhao

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Capital Medical University

Central Contacts

P.H. Wei

Role: CONTACT

weipenghu@xwhosp.org

+86-010-83198252

Other Identifiers

LYS-[2020]-051

Identifier Type: -

Identifier Source: org_study_id