taVNS for Speech and Language Recovery in Aphasia

Non-invasive Vagus Nerve Stimulation for Language Recovery in Aphasia

The goal of this research study is to evaluate a novel approach to improving speech recovery in those with acquired apraxia of speech. We will enroll participants with apraxia of speech resulting from stroke or brain injury to complete several tasks and intervention. Testing will take place four times over the course of the study and intervention will take place 5 days a week for 16 weeks. Overall, you can expect to spend up to 17 weeks participating in this study.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aphasia; Apraxia of Speech
• Intervention / Treatment: Device: taVNS; Device: sham taVNS

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Brooks Rehabilitation Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults between 18-80
• Native speakers of English or simultaneous bilinguals
• At least 6 months post stroke or TBI
• Diagnosed production type aphasia or apraxia of speech

Exclusion Criteria:

• Additional cognitive or neurological impairments (Autism, schizophrenia, seizures, etc)
• Language comprehension deficits
• Medications that influence key neurotransmitters

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; non-invasive vagus nerve stimulation is administered alongside standard intervention	Device: taVNS; active vagus nerve stimulation
Placebo Comparator: Treatment B; sham stimulation is administered alongside standard intervention	Device: sham taVNS; sham vagus nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.	6 months
Compliance	Percentage of the population that remains engaged in the study and completes all stimulation sessions.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in speech production scores	Primary outcomes for this aim include the learning trajectory over 8 weeks of speech therapy as measured by weekly probes and the WAB when intervention is combined with taVNS versus control stimulation to determine the effect of taVNS on re-learning motor speech plans and the trajectory of motor speech recovery.	6 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Eric Sorenson Motor Speech Program at Brooks Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: stroke; language; traumatic brain injury; speech; vagus nerve stimulation; taVNS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Psychomotor Disorders; Communication Disorders; Brain Injuries; Language Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Communication; Verbal Behavior; Brain Injuries, Traumatic; Stroke; Aphasia; Apraxias; Speech; Language
• Other Study ID Numbers: IRB202501105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No