Atlas of Intracranial Recordings on Cortical Responses After Functional tACS

Transcranial Alternating Current Stimulation Clinical Trial

— AIRCRAFT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04560959
• Other study ID #: LYS-[2020]-051
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 20, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2020
• Source: Xuanwu Hospital, Beijing
• Contact: P.H. Wei
• Phone: +86-010-83198252
• Email: weipenghu[@]xwhosp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Transcranial Alternating Current Stimulation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.