Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-27 @ 6:55 AM
Study NCT ID:
NCT06127550
Status:
SUSPENDED
Last Update Posted:
2025-12-11
First Post:
2023-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
taVNS for Letter Learning in Dyslexia
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Effect of Non-invasive Vagus Nerve Stimulation on Letter Learning in Dyslexia
Status:
SUSPENDED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Waiting on funding to support study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study to establish feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) for improving letter-learning in adolescents with dyslexia. The main goals of the study are to 1) evaluate whether children in this age range will tolerate low level stimulation over the course of multiple sessions, 2) determine whether low level taVNS improves novel letter learning in dyslexia, and 3) evaluate the effect of low level taVNS on the brain's response to letters. Participants will complete fMRI before training, immediately after training, and a few weeks after training ends. Training will consist of six 30-minute lessons during which participants will learn novel letter-sound relationships while receiving either active or sham taVNS. Researchers will compare stimulation conditions to determine effect of this device on learning and neural plasticity.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: