TBI Traumatic Brain InjuryNCT07428980
Noninvasive Brain Stimulation to Enhance Cognition at Home Following a TBI.
A study testing Transcutaneous Vagus Nerve Stimulation (tVNS) in people with TBI Traumatic Brain Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous vagus nerve stimulation (tVNS) at home, to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TBI Traumatic Brain Injury
- What is being tested?
- Transcutaneous Vagus Nerve Stimulation (tVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to 27 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Formally diagnosed with traumatic brain injury.
- Ability to independently use a keyboard.
- Able to understand and communicate in English (according to clinical judgment).
- Able to independently provide consent to participate.
Who cannot join
- Acute medical issues requiring close physician or nursing monitoring.
- Bioelectrical implants, cerebral shunts, including pacemakers.
- Anyone with sore or diseased skin area in the ear
- Pregnancy or persons who are lactating.
- Cardiac arrhythmia.
- Epilepsy or seizure disorders.
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- Significant gross or fine motor weakness.
- Significant, ongoing communication or comprehension impairments (such as aphasia) that would affect an individual's ability to complete the required assessments.
- Severely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test attached to this submission).
- Current major depression diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Cognition After TBI Using Noninvasive Vagus Nerve Stimulation at Home
The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous vagus nerve stimulation (tVNS) at home, to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).
Read the detailed description
This is a single-blind, open-label pilot study to evaluate the feasibility and preliminary efficacy of remotely supervised, at-home delivery of tVNS in individuals with moderate to severe TBI during the post-acute recovery phase. Eligible participants will complete a 2-week tVNS intervention protocol at home. Mixed methods (quantitative and qualitative) will be used to evaluate outcomes. Eligible participants will be invited to initial baseline assessment and tVNS training session (Visit 1). Then, they will complete two weeks of at-home administration period. Lastly, they will return to a post- stimulation assessment (Visit 2). In the assessment sessions participants will complete tasks of set shifting and working memory, core executive functions, as well as complete surveys regarding fatigue, sleep, and overall quality of life.
- Conditions
- TBI Traumatic Brain Injury
- Being tested
- Transcutaneous Vagus Nerve Stimulation (tVNS)
- Keywords
- Traumatic Brain Injury, Vagus Nerve, Executive Functions, Transcutaneous Vagus Nerve Stimulation (tVNS)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Vagus Nerve Stimulation (tVNS)Device
Also called Transcutaneous auricular vagus nerve stimulation (taVNS)
tVNS stimulation, one hour a day, for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Active stimulation using trans auricular nerve stimulation device (tVNS), one hour a day for 14 days at home. Pre and post assessment occurring at day 0 and day 15. Receives: Device: Transcutaneous Vagus Nerve Stimulation (tVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who successfully completed 75% of the sessions.
Recording the number of participant who completed at least 75% of the sessions out of the number of participants enrolled in the study.
Measured: Day 15
Participant-Reported Acceptability of Home-Based tVNS Therapy
Completion of the Treatment Acceptability/Adherence Scale at baseline (day 0) and post stimulation assessment (day 15)
Measured: Day 0 and Day 15
Secondary outcomes (3)
N-Back task
In the N-Back Task, participants are presented a series of visual stimuli. They are asking for each stimulus whether is matches a stimulus n-trials before. For example, in a 2-back task, in which the trials consist of letters, participants have to decide whether the current letter is the same as the letter in the trial n-2. We will use a computerized version of this task.
Measured: Day 0 Baseline and Day 15 Post Stimulation Assessment
California Verbal Learning Test
The California Verbal Learning Test evaluates the ability to encode, recall, and recognize verbally presented information across multiple learning trials and delayed recall conditions. Participants are read multiple lists of words and asked to recall specific words at different time allotments.
Measured: Day 0 Baseline and Day 15 Post Stimulation Assessment
Trail Making Test A&B
Trail Making Part A requires participant to draw a line between circles containing numbers in ascending order. Part B requires participants to alternate drawing a line between ascending letters and numbers. The key measures are the time required to complete and the number of errors made in Part A and Part B. The test measures various aspects of cognition including attention, visual search, motor coordination, reasoning, and task switching.
Measured: Day 0 Baseline and Day 15 Post Stimulation Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start9 Jan 2026
- Primary completion27 Apr 2026
- Study completion27 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Shira Cohen-Zimerman, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428980
- Sponsor's protocol ID
- STU00225204
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2026
- Last updated
- 18 Jun 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognition After TBI Using Noninvasive Vagus Nerve Stimulation at Home
- ClinicalTrials.gov ID
- NCT07428980
- Acronym / sponsor ID
- STU00225204
- Conditions
- TBI Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Vagus Nerve, Executive Functions, Transcutaneous Vagus Nerve Stimulation (tVNS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 24 Feb 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 purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous vagus nerve stimulation (tVNS) at home, to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).
Detailed description
This is a single-blind, open-label pilot study to evaluate the feasibility and preliminary efficacy of remotely supervised, at-home delivery of tVNS in individuals with moderate to severe TBI during the post-acute recovery phase. Eligible participants will complete a 2-week tVNS intervention protocol at home. Mixed methods (quantitative and qualitative) will be used to evaluate outcomes. Eligible participants will be invited to initial baseline assessment and tVNS training session (Visit 1). Then, they will complete two weeks of at-home administration period. Lastly, they will return to a post- stimulation assessment (Visit 2). In the assessment sessions participants will complete tasks of set shifting and working memory, core executive functions, as well as complete surveys regarding fatigue, sleep, and overall quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: Transcutaneous Vagus Nerve Stimulation (tVNS)Active stimulation using trans auricular nerve stimulation device (tVNS), one hour a day for 14 days at home. Pre and post assessment occurring at day 0 and day 15. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years.
Key exclusion criteria (10 listed)
- Acute medical issues requiring close physician or nursing monitoring.
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 |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation (tVNS)Also: Transcutaneous auricular vagus nerve stimulation (taVNS)tVNS stimulation, one hour a day, for 14 days. | Device | Active Stimulation |
Primary outcome
Number of participants who successfully completed 75% of the sessions.
Time frame: Day 15
Recording the number of participant who completed at least 75% of the sessions out of the number of participants enrolled in the study.
Participant-Reported Acceptability of Home-Based tVNS Therapy
Time frame: Day 0 and Day 15
Completion of the Treatment Acceptability/Adherence Scale at baseline (day 0) and post stimulation assessment (day 15)
3 secondary outcomes
N-Back task
Time frame: Day 0 Baseline and Day 15 Post Stimulation Assessment
California Verbal Learning Test
Time frame: Day 0 Baseline and Day 15 Post Stimulation Assessment
Trail Making Test A&B
Time frame: Day 0 Baseline and Day 15 Post Stimulation Assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Transcutaneous Vagus Nerve Stimulation (tVNS) in people with TBI Traumatic Brain Injury, run by Shirley Ryan AbilityLab 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 18 Jun 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants who successfully completed 75% of the sessions. (time frame: Day 15). 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 18 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.