taVNS for Dyslexia

Overseen By Tracy Centanni, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Non-ADHD medications

Disqualifiers: Autism, Epilepsy, Low nonverbal IQ, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow medications prescribed for ADHD.

How does the taVNS treatment for dyslexia differ from other treatments?

taVNS (transcutaneous auricular vagus nerve stimulation) is unique because it involves stimulating the vagus nerve through the skin of the ear, which is different from traditional dyslexia treatments that often focus on educational interventions. This approach is novel as it targets neurological pathways potentially involved in dyslexia, rather than relying solely on behavioral or educational strategies. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adolescents with dyslexia who can read at a certain level (scores above or below 90 on reading measures) and have normal non-verbal IQ. It's not for those with other neurological conditions like autism or epilepsy, nor for those taking medications besides ADHD prescriptions.

Inclusion Criteria

You read very well, or you have trouble reading and may have ADHD.

You have a normal non-verbal IQ.

Exclusion Criteria

I am not on ADHD medication.

Your nonverbal IQ is lower than 80.

You have a neurological condition like autism or epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six 30-minute lessons to learn novel letter-sound relationships while receiving either active or sham taVNS

4 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including fMRI assessments

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• active taVNS
• sham taVNS

Trial Overview The study tests if taVNS, a low-level nerve stimulation given during letter-learning sessions, helps improve reading skills in dyslexic teens. Participants will receive either real taVNS or sham (fake) treatment to see which is more effective.

How Is the Trial Designed?

Group I: Active taVNS Experimental Treatment 1 Intervention

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

Group II: Sham taVNS Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Brivaracetam (BRV) shows a significantly higher affinity for the synaptic vesicle protein SV2A compared to levetiracetam, which correlates with its strong antiepileptic activity in animal models.

BRV inhibits voltage-dependent sodium currents in rat neocortical neurons in a concentration-dependent manner, suggesting that this modulation of sodium inflow may contribute to its effectiveness as an antiepileptic drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brivaracetam (ucb 34714) inhibits Na(+) current in rat cortical neurons in culture. Zona, C., Pieri, M., Carunchio, I., et al.[2016]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Brivaracetam (ucb 34714) inhibits Na(+) current in rat cortical neurons in culture. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Expression of human A53T alpha-synuclein in the rat substantia nigra using a novel AAV1/2 vector produces a rapidly evolving pathology with protein aggregation, dystrophic neurite architecture and nigrostriatal degeneration with potential to model the pathology of Parkinson's disease. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Healthy and diseased corticospinal motor neurons are selectively transduced upon direct AAV2-2 injection into the motor cortex. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

SCN1A splice variants exhibit divergent sensitivity to commonly used antiepileptic drugs. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Adeno-Associated Viral Vectors in Neuroscience Research. [2020]