taVNS for Letter Learning in Dyslexia

NCT ID: NCT06127550

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-08-01

Study Completion Date

2029-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslexia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to either active stimulation or sham stimulation groups.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active taVNS

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

Group Type EXPERIMENTAL

active taVNS

Intervention Type DEVICE

low level stimulation to the auricular branch of the vagus nerve

Sham taVNS

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

Group Type SHAM_COMPARATOR

sham taVNS

Intervention Type DEVICE

device placed with no current administered

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

active taVNS

low level stimulation to the auricular branch of the vagus nerve

Intervention Type DEVICE

sham taVNS

device placed with no current administered

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB202301883

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.