Atlas of Intracranial Recordings on Cortical Responses After Functional tACS (AIRCRAFT)

An Atlas of Cerebral Responses to the Stimuli of the tACS Recorded by SEEG

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

Study Overview

• Status: Unknown
• Conditions: Transcranial Alternating Current Stimulation
• Intervention / Treatment: Device: tACS

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: tACS; tACS would be performed to epilepsy patients who have already received implantation of the SEEG electrodes

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: G.G. Zhao, Department of Neurosurgery, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: LYS-[2020]-051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes