taVNS for Letter Learning in Dyslexia

University of Florida

Status: Suspended

Conditions: Dyslexia

Treatments: Device: active taVNS; Device: sham taVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT06127550

IRB202301883

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Active taVNS

Experimental group

Description:

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

Treatment:

Device: active taVNS

Sham taVNS

Sham Comparator group

Description:

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

Treatment:

Device: sham taVNS