Dyslexia
Conditions
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.
Interventions
DEVICEactive taVNS
low level stimulation to the auricular branch of the vagus nerve
DEVICEsham taVNS
device placed with no current administered
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Participants will be randomly assigned to either active stimulation or sham stimulation groups.
Eligibility
Sex/Gender
ALL
Age
10 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 4 weeks | Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition. |
| Compliance | 4 weeks | Percentage of the population that remains engaged in the study and completes all stimulation sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Letter ID | 6 weeks | Percent correct of learned letter-sound relationships |
| Decoding | 6 weeks | Percent correct of pseudowords read in 45 seconds |
| Automaticity | 6 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| fMRI | 6 weeks | Strength of the brain's response to learned letters in the visual word form area |
Countries
United States
Outcome results
None listed