DyslexiaNCT06127550
taVNS for Letter Learning in Dyslexia
A study testing active taVNS in people with Dyslexia, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia
- What is being tested?
- active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Neurological diagnoses (e.g., autism, epilepsy, etc.)
- Medications other than those prescribed for ADHD
- Nonverbal IQ below 80
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-invasive Vagus Nerve Stimulation on Letter Learning in Dyslexia
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.
- Conditions
- Dyslexia
- Being tested
- active taVNS, sham taVNS
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active taVNSDevice
low level stimulation to the auricular branch of the vagus nerve
sham taVNSDevice
device placed with no current administered
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: active taVNS |
| Sham taVNS | Sham comparator | Participants will undergo current thresholding but device will be turned off without their knowledge during the training. Receives: Device: sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.
Measured: 4 weeks
Compliance
Percentage of the population that remains engaged in the study and completes all stimulation sessions.
Measured: 4 weeks
Secondary outcomes (3)
Letter ID
Percent correct of learned letter-sound relationships
Measured: 6 weeks
Decoding
Percent correct of pseudowords read in 45 seconds
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Sep 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Why it stopped: Waiting on funding to support study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either active stimulation or sham stimulation groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127550
- Sponsor's protocol ID
- IRB202301883
- Status last verified
- May 2026
- First submitted
- 27 Oct 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-invasive Vagus Nerve Stimulation on Letter Learning in Dyslexia
- ClinicalTrials.gov ID
- NCT06127550
- Acronym / sponsor ID
- IRB202301883
- Conditions
- Dyslexia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Waiting on funding to support study
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either active stimulation or sham stimulation groups.
| Arm | Type | Receives |
|---|---|---|
| Active taVNS | Experimental | Device: active taVNSParticipants 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 | Device: sham taVNSParticipants will undergo current thresholding but device will be turned off without their knowledge during the training. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Neurological diagnoses (e.g., autism, epilepsy, etc.)
- Medications other than those prescribed for ADHD
- Nonverbal IQ below 80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active taVNSlow level stimulation to the auricular branch of the vagus nerve | Device | Active taVNS |
| sham taVNSdevice placed with no current administered | Device | Sham taVNS |
Primary outcome
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.
3 secondary outcomes
Letter ID
Time frame: 6 weeks
Decoding
Time frame: 6 weeks
Automaticity
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active taVNS in people with Dyslexia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.