AphasiaNCT07563387
taVNS for Speech and Language Recovery in Aphasia
A study testing taVNS in people with Aphasia and Apraxia of Speech, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphasia, Apraxia of Speech
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Additional cognitive or neurological impairments (Autism, schizophrenia, seizures, etc)
- Language comprehension deficits
- Medications that influence key neurotransmitters
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brooks Rehabilitation Clinical Research Center
Jacksonville, Florida, 32216
About this study
Official title: 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.
- Conditions
- Aphasia, Apraxia of Speech
- Being tested
- taVNS, sham taVNS
- Keywords
- taVNS, vagus nerve stimulation, stroke, traumatic brain injury, language, speech
- Medical subject headings
- Aphasia, Apraxias, Stroke, Brain Injuries, Traumatic, Language, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
active vagus nerve stimulation
sham taVNSDevice
sham vagus nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | non-invasive vagus nerve stimulation is administered alongside standard intervention Receives: Device: taVNS |
| Treatment B | Placebo comparator | sham stimulation is administered alongside standard intervention 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: 6 months
Compliance
Percentage of the population that remains engaged in the study and completes all stimulation sessions.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Eric Sorenson Motor Speech Program at Brooks Rehabilitation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563387
- Sponsor's protocol ID
- IRB202501105
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Vagus Nerve Stimulation for Language Recovery in Aphasia
- ClinicalTrials.gov ID
- NCT07563387
- Acronym / sponsor ID
- IRB202501105
- Conditions
- Aphasia, Apraxia of Speech
- Keywords
- taVNS, vagus nerve stimulation, stroke, traumatic brain injury, language, speech
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Eric Sorenson Motor Speech Program at Brooks Rehabilitation
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 4 May 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Device: taVNSnon-invasive vagus nerve stimulation is administered alongside standard intervention |
| Treatment B | Placebo comparator | Device: sham taVNSsham stimulation is administered alongside standard intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Additional cognitive or neurological impairments (Autism, schizophrenia, seizures, etc)
- Language comprehension deficits
- Medications that influence key neurotransmitters
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 |
|---|---|---|
| taVNSactive vagus nerve stimulation | Device | Treatment A |
| sham taVNSsham vagus nerve stimulation | Device | Treatment B |
Primary outcome
Adverse events
Time frame: 6 months
Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.
Compliance
Time frame: 6 months
Percentage of the population that remains engaged in the study and completes all stimulation sessions.
1 secondary outcome
Change in speech production scores
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
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 taVNS in people with Aphasia and Apraxia of Speech, 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 4 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: enrolling by invitation, as of the sponsor's last update on 4 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?
This study is still under way. Results are not available in the source record yet.
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: 6 months). 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 4 May 2026.