taVNS for Letter Learning in Dyslexia

NCT06127550 | Suspended FDA Device

• 1 other identifier: IRB202301883
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslexia

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.

  4 weeks

• Compliance

  Percentage of the population that remains engaged in the study and completes all stimulation sessions.

  4 weeks

Secondary Outcomes (3)

• Letter ID

  6 weeks

• Decoding

  6 weeks

• Automaticity

  6 weeks

Other Outcomes (1)

• fMRI

  6 weeks

Study Arms (2)

Active taVNS

EXPERIMENTAL

Participants will receive custom current at 5 Hz to the left auricular branch of the vagus nerve while learning new letter-sound relationships.

Device: active taVNS

Sham taVNS

SHAM COMPARATOR

Participants will undergo current thresholding but device will be turned off without their knowledge during the training.

Device: sham taVNS

Interventions

sham taVNS DEVICE

device placed with no current administered

Sham taVNS

active taVNS DEVICE

low level stimulation to the auricular branch of the vagus nerve

Active taVNS

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants will be told they are receiving active stimulation at a custom current level that may or may not be detectable to them. Half of the participants (randomly assigned) will not receive stimulation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either active stimulation or sham stimulation groups.

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 13, 2023
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 11, 2025

Record last verified: 2025-02

Locations

US (1)