taVNS for Speech and Language Recovery in Aphasia

NCT07563387 | Enrolling By Invitation FDA Device

• 1 other identifier: IRB202501105
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aphasia; Apraxia of Speech

Keywords

taVNS; vagus nerve stimulation; stroke; traumatic brain injury; language; speech

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in speech production scores

  6 months

Study Arms (2)

Treatment A

EXPERIMENTAL

non-invasive vagus nerve stimulation is administered alongside standard intervention

Device: taVNS

Treatment B

PLACEBO COMPARATOR

sham stimulation is administered alongside standard intervention

Device: sham taVNS

Interventions

taVNS DEVICE

active vagus nerve stimulation

Treatment A

sham taVNS DEVICE

sham vagus nerve stimulation

Treatment B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• Eric Sorenson Motor Speech Program at Brooks Rehabilitation: collaborator

Study Sites (1)

Brooks Rehabilitation Clinical Research Center

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Aphasia; Apraxias; Stroke; Brain Injuries, Traumatic; Language; Speech

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Psychomotor Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Communication; Behavior; Verbal Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: May 4, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)