Effect of Non-invasive Vagus Nerve Stimulation on Letter Learning in Dyslexia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dyslexia
- Sponsor
- University of Florida
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Suspended
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adverse events
Time Frame: 4 weeks
Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.
Compliance
Time Frame: 4 weeks
Percentage of the population that remains engaged in the study and completes all stimulation sessions.
Secondary Outcomes
- Letter ID(6 weeks)
- Decoding(6 weeks)
- Automaticity(6 weeks)