Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334952
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-28
First Post:
2024-03-16
Brief Title:
Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation tDCS in Drug-resistant Epileptic
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Model-based Multichannel Transcranial Direct Current Electrical Stimulation tDCS in Drug-resistant Epilepsy a Cross-over Study of Efficacy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GALVANI GS-3
Brief Summary:
The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS compared to sham stimulation drug-resistant epileptic patient The main questions it aims to answer are
Changes in quality of life
Percent of newly reported side effects after the stimulation period
Scores in epilepsy severity Participants will be randomized in a cross-over and will receive 10 days of tDCS or Sham Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off with 40 minutes of cathodal stimulation total
Changes in quality of life
Percent of newly reported side effects after the stimulation period
Scores in epilepsy severity Participants will be randomized in a cross-over and will receive 10 days of tDCS or Sham Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off with 40 minutes of cathodal stimulation total
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID-RCB | OTHER | 2023-A02482-43 | None |