taVNS for Letter Learning in Dyslexia

Dyslexia Clinical Trial

Official title:

Effect of Non-invasive Vagus Nerve Stimulation on Letter Learning in Dyslexia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127550
• Other study ID #: IRB202301883
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 1, 2029

Study information

• Verified date: February 2024
• Source: University of Florida
• Contact: Tracy Centanni, PhD
• Phone: 3522948675
• Email: tracy.centanni[@]phhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2029
• Est. primary completion date: August 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

Inclusion Criteria:

• Normal non-verbal IQ
• Reading scores above 90 on four single word reading measures (typical reader) OR reading scores below 90 on two or more single word reading measures (dyslexia) with or without ADHD

Exclusion Criteria:

• Neurological diagnoses (e.g., autism, epilepsy, etc.)
• Medications other than those prescribed for ADHD
• Nonverbal IQ below 80

Related Conditions & MeSH terms

• Dyslexia

Intervention

Device:
• active taVNS
low level stimulation to the auricular branch of the vagus nerve
• sham taVNS
device placed with no current administered

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fMRI	Strength of the brain's response to learned letters in the visual word form area	6 weeks
Primary	Adverse events	Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.	4 weeks
Primary	Compliance	Percentage of the population that remains engaged in the study and completes all stimulation sessions.	4 weeks
Secondary	Letter ID	Percent correct of learned letter-sound relationships	6 weeks
Secondary	Decoding	Percent correct of pseudowords read in 45 seconds	6 weeks
Secondary	Automaticity	This measure is based on a standardized measure for rapid letter naming in English (CTOPP-Rapid Automatized Naming) in which the participant is shown a grid of many letters in Hebrew and are asked to read the grid as quickly and accurately as possible while being timed.	6 weeks