taVNS for Dyslexia

TC
Overseen ByTracy Centanni, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a gentle nerve stimulation technique, known as transcutaneous auricular Vagus Nerve Stimulation (taVNS), can help adolescents with dyslexia improve their letter-learning skills. The technique uses a device to deliver low-level stimulation to a nerve in the ear, potentially enhancing the brain's response to letters. Participants will undergo several short training sessions to determine if this method eases the process of learning new letters. The trial seeks teens diagnosed with dyslexia who are not taking medications other than those for ADHD. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could lead to new learning strategies for dyslexia.

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.

What prior data suggests that this device is safe for adolescents with dyslexia?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe. Participants in studies have tolerated it well. Most side effects, such as mild skin irritation, are minor and temporary. No evidence indicates serious harm from using taVNS. In summary, based on current data, taVNS appears to be a safe treatment option.12345

Why are researchers excited about this trial?

Most treatments for dyslexia focus on educational interventions and behavioral therapies to improve reading skills. But the taVNS (transcutaneous auricular Vagus Nerve Stimulation) approach is different because it targets the brain's neural pathways directly. Researchers are excited about taVNS because it uses a gentle electrical current to stimulate the vagus nerve, potentially enhancing the brain's ability to form new connections during learning. This is a novel mechanism compared to traditional methods, and it could offer a non-invasive, quick-acting option for improving literacy in people with dyslexia.

What evidence suggests that taVNS is effective for improving letter-learning in dyslexia?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) might aid learning and memory. One study found that taVNS improved reading skills in adults, suggesting it might also assist with learning letters. Another study discovered that individuals who received this stimulation had slightly better reading comprehension scores than those who did not. While these results are promising, the effects may vary depending on the type of mental task. In this trial, participants will receive either active taVNS or sham taVNS to explore its potential to help teenagers with dyslexia learn letters.56789

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 have a normal non-verbal IQ.
You read very well, or you have trouble reading and may have ADHD.

Exclusion Criteria

Your nonverbal IQ is lower than 80.
I am not on ADHD medication.
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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active taVNSExperimental Treatment1 Intervention
Group II: Sham taVNSPlacebo Group1 Intervention

Find a Clinic Near You

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

Citations

The effect of non-invasive vagus nerve stimulation on ...These findings suggest that taVNS may be beneficial for enhancing memory, but its efficacy may be limited in higher cognitive domains.
taVNS for Letter Learning in Dyslexia - MedPathThis is a pilot study to establish feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) for improving letter-learning in adolescents with ...
Transcutaneous auricular vagus nerve stimulation ...These results demonstrate, for the first time, that taVNS is capable of improving aspects of reading acquisition in adults.
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36265760/
The effect of non-invasive vagus nerve stimulation on ...These findings suggest that taVNS may be beneficial for enhancing memory, but its efficacy may be limited in higher cognitive domains.
The Effect of Transcutaneous Auricular Vagus Nerve ...Reading comprehension data suggests that TD individuals who received taVNS stimulation had marginally higher reading comprehension scores than TD sham ...
Safety of transcutaneous auricular vagus nerve stimulation ...The author concluded that transcutaneous vagus nerve stimulation is well tolerated and safe, with only mild side effects such as local skin ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36543841/
Safety of transcutaneous auricular vagus nerve stimulation ...Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet ...
No clear benefit of transcutaneous auricular vagus nerve ...The present study does not find that taVNS holds benefits for the acquisition of new speech sounds; however, the field is nascent.
Study Details | NCT06258590 | taVNS for Anxiety in ASDThis pilot trial will be an open-label investigation of the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) as a ...
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