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Enrolling by invitationNCT06127550Updated Nov 9, 2026

taVNS for Letter Learning in Dyslexia

An interventional study of active taVNS and sham taVNS in Dyslexia, sponsored by University of Florida. Enrolling by invitation at 1 site in United States. Open to participants aged 10 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University of Florida · Not applicable, Interventional, and Basic science

Updated Nov 9, 2026Now Enrolling by invitationStart date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
10 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dyslexia

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03

In context

Dyslexia

127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's planned enrollment of 100 is above the median of 71 across 106 interventional studies indexed under Dyslexia.

Browse Dyslexia studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Neurological diagnoses (e.g., autism, epilepsy, etc.)
  • Medications other than those prescribed for ADHD
  • Nonverbal IQ below 80
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Active taVNS

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

    Device: active taVNS

  • Sham comparator
    Sham taVNS

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

    Device: sham taVNS

Interventions

  • Deviceactive taVNS

    low level stimulation to the auricular branch of the vagus nerve

  • Devicesham taVNS

    device placed with no current administered

06

What researchers measure

Primary outcomes

  1. Adverse events

    Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.

    Time frame: 4 weeks

  2. Compliance

    Percentage of the population that remains engaged in the study and completes all stimulation sessions.

    Time frame: 4 weeks

Secondary outcomes

  1. Letter ID

    Percent correct of learned letter-sound relationships

    Time frame: 6 weeks

  2. Decoding

    Percent correct of pseudowords read in 45 seconds

    Time frame: 6 weeks

  3. 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.

    Time frame: 6 weeks

Other outcomes

  1. fMRI

    Strength of the brain's response to learned letters in the visual word form area

    Time frame: 6 weeks

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2026 (actual). Primary completion is estimated for Aug 2028, 21 months after the start.

Of 62 non-industry interventional studies with no phase under Dyslexia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's planned 21 months is below that.

Counting every sponsor, half of 69 studies reached it within 24 months; a quarter within 9 and three quarters within 57.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 9, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2023
First posted
Nov 13, 2023
StartActual
Nov 1, 2026was Sep 2026
Primary completionEst.
Aug 1, 2028
CompletionEst.
Sep 1, 2029
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Suspended→Enrolling by invitation Reason for stopping removed
changed Nov 9, 2026
Start date
Sep 1, 2026→Nov 1, 2026 (actual)
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Suspended→Enrolling by invitation
    Why stopped Reason for stopping removed
    Start date Sep 1, 2026→Nov 1, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06127550
Responsible party
Sponsor
First posted
Nov 13, 2023
Start date
Nov 1, 2026
Primary completion
Aug 1, 2028 (estimated)
Completion
Sep 1, 2029 (estimated)
Last update
Nov 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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