taVNS for Letter Learning in Dyslexia

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06127550

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dyslexia	Device: active taVNS Device: sham taVNS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to either active stimulation or sham stimulation groups.Participants will be randomly assigned to either active stimulation or sham stimulation groups.

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Basic Science

Official Title:

Effect of Non-invasive Vagus Nerve Stimulation on Letter Learning in Dyslexia

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2028

Anticipated Study Completion Date :

Sep 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
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 low level stimulation to the auricular branch of the vagus nerve
Sham Comparator: Sham taVNS Participants will undergo current thresholding but device will be turned off without their knowledge during the training.	Device: sham taVNS device placed with no current administered

Arm

Intervention/Treatment

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

low level stimulation to the auricular branch of the vagus nerve

Sham Comparator: Sham taVNS

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

Device: sham taVNS

device placed with no current administered

Outcome Measures

Primary Outcome Measures

Automaticity [3 weeks]
Time taken to read a card of letters accurately

Secondary Outcome Measures

Letter ID [3 weeks]
Percent correct of learned letter-sound relationships
Decoding [3 weeks]
Percent correct of pseudowords read in 45 seconds

Other Outcome Measures

fMRI [3 weeks]
Strength of the brain's response to learned letters in the visual word form area

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT06127550

Other Study ID Numbers:

IRB202301883

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dyslexia

Study Results

No Results Posted as of Nov 13, 2023