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Waiting on funding to support study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Sham taVNS | Sham Comparator | Participants will undergo current thresholding but device will be turned off without their knowledge during the training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active taVNS | Device | low level stimulation to the auricular branch of the vagus nerve |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Letter ID | Percent correct of learned letter-sound relationships | 6 weeks |
| Decoding | Percent correct of pseudowords read in 45 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI | Strength of the brain's response to learned letters in the visual word form area | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D004410 | Dyslexia |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Participants will be randomly assigned to either active stimulation or sham stimulation groups.
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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.
| sham taVNS |
| Device |
device placed with no current administered |
|
| 6 weeks |
| Automaticity | 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. | 6 weeks |
| D009422 | Nervous System Diseases |
| D000067559 | Specific Learning Disorder |
| D007859 | Learning Disabilities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |