Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558890
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study on the Efficacy and Mechanism of Targeted Cerebellar Transcranial Electrical Stimulation for the Treatment of Refractory Temporal Lobe Epilepsy A Single-center Observational Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study the therapeutic effect and potential neural mechanisms of transcranial electrical stimulation targeting the cerebellum for the treatment of refractory temporal lobe epilepsy through MRI and EEG
Detailed Description:
This study is a single-center observational studyThis study applies transcranial alternating current stimulation to the cerebellum of patients with refractory temporal lobe epilepsyFor the recruited patients with refractory TLE Temporal Lobe Epilepsy they will undergo a 6-week treatment with tACS transcranial alternating current stimulation protocol 2mA 10Hz 20 minutes per side following a schedule of treatment for 5 days - rest for 2 days - treatment for another 5 days and then a reinforcement treatment once a week completing a total of 14 treatmentsBefore treatment at week 10 and at week 14 the frequency of epileptic seizures and the QOLIE-31 questionnaire scores will be recorded and assessed for the patients EEG data and near-infrared spectroscopy NIRS brain functional imaging data will be collected before treatment and after two consecutive weeks of treatment Magnetic resonance imaging MRI data will be acquired before treatment after two consecutive weeks of treatment and after six weeks of intensified treatment Appropriate image processing methods and EEG processing methods will be utilized to analyze the changes in brain networks following tACS treatment in order to explore the impact of tACS on the neural mechanisms of refractory temporal lobe epilepsy TLE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None