Traumatic Brain InjuryNCT06589362
Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation
A study testing Transcutaneous auricular vagus active nerve stimulation in people with 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 auricular vagus nerve stimulation (tVNS) 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 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Transcutaneous auricular vagus active nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2024to Aug 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In inpatient rehabilitation due to recent Traumatic Brain Injury, ages 18-65 years.
- Ability to independently use a keyboard. Able to understand and communicate in English (according to clinical judgment). Able to independently provide consent to participate. Orientation to place, time, and situation (two consecutive scores of 25 or more on the Orientation Log(O-Log)40. This scale is routinely administered during acute rehabilitation stay.
Who cannot join
- Acute medical issues requiring close physician or nursing monitoring. Bioelectrical implants, including pacemakers. Pregnancy or persons who are lactating. 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.
- Acute agitation or behavioral issues, as defined by a last Agitated Behavior Scale Score greater than 21 (routinely administered during acute rehabilitation stay, that would affect an individual's ability to participate in the required assessments.
- Severely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test, routinely administered during acute rehabilitation stay.
- Diagnosis of depression. Active substance abuse.
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, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60610
Katy Magee, M.H.S. SLP, 312-238-6451, kmagee02@sralab.org
About this study
Official title: Enhancing Cognitive Rehabilitation After TBI Using Noninvasive Vagal Nerve Stimulation
The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).
Read the detailed description
Eligible participants will be invited to two sessions, 2-7 days apart. In each session, either active tVNS or sham stimulation will be administered while the participants are performing tasks of executive functions. The order of the sessions (tVNS vs Sham) will be counterbalanced across participants.
- Conditions
- Traumatic Brain Injury
- Being tested
- Transcutaneous auricular vagus active nerve stimulation, Transcutaneous auricular vagus sham nerve stimulation
- 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 auricular vagus active nerve stimulationDevice
In the active stimulation, two electrodes are placed in the cymba conchae of one of the ears, an area thought to be exclusively innervated by the auricular branch of the vagus nerve.
Transcutaneous auricular vagus sham nerve stimulationDevice
In the sham stimulation, the electrodes are placed on the tail of helix, which is free of vagal innervation.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation | Active comparator | Active vagus nerve stimulation. Receives: Device: Transcutaneous auricular vagus active nerve stimulation |
| Sham Transcutaneous auricular vagus nerve stimulation | Sham comparator | Sham vagus nerve stimulation. Receives: Device: Transcutaneous auricular vagus sham nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-Back Computerized Task
In the n-back task, participants are presented a series of visual stimuli. They are asked for each stimulus whether it 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 trial n - 2. We will use a computerized version of this task.
Measured: 15 minutes
Trail Making Test - Parts A & B
Trail Making Part A requires participants to draw a line between circles containing numbers in ascending order (e.g., 1-2- 3...etc.). Part B requires participants to alternate drawing a line between ascending letters and numbers (e.g., 1-A-2-B...etc.). The key measures are the time required to complete and the number of errors made in Part A and Part B. This test measures various aspects of cognition including attention, visual search, motor coordination, reasoning, and task-switching.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Crossover
- Model description
- a single-blind sham-controlled randomized crossover pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shira Cohen-Zimerman, Shirley Ryan AbilityLab
- Investigators
- Shira Cohen-Zimerman, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589362
- Sponsor's protocol ID
- STU00221084
- Status last verified
- Mar 2025
- First submitted
- 5 Sep 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognitive Rehabilitation After TBI Using Noninvasive Vagal Nerve Stimulation
- ClinicalTrials.gov ID
- NCT06589362
- Acronym / sponsor ID
- STU00221084
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (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 auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).
Detailed description
Eligible participants will be invited to two sessions, 2-7 days apart. In each session, either active tVNS or sham stimulation will be administered while the participants are performing tasks of executive functions. The order of the sessions (tVNS vs Sham) will be counterbalanced across participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a single-blind sham-controlled randomized crossover pilot study
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation | Active comparator | Device: Transcutaneous auricular vagus active nerve stimulationActive vagus nerve stimulation. |
| Sham Transcutaneous auricular vagus nerve stimulation | Sham comparator | Device: Transcutaneous auricular vagus sham nerve stimulationSham vagus nerve stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In inpatient rehabilitation due to recent Traumatic Brain Injury, ages 18-65 years.
- Ability to independently use a keyboard. Able to understand and communicate in English (according to clinical judgment). Able to independently provide consent to participate. Orientation to place, time, and situation (two consecutive scores of 25 or more on the Orientation Log(O-Log)40. This scale is routinely administered during acute rehabilitation stay.
Key exclusion criteria (4 listed)
- Acute medical issues requiring close physician or nursing monitoring. Bioelectrical implants, including pacemakers. Pregnancy or persons who are lactating. 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.
- Acute agitation or behavioral issues, as defined by a last Agitated Behavior Scale Score greater than 21 (routinely administered during acute rehabilitation stay, that would affect an individual's ability to participate in the required assessments.
- Severely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test, routinely administered during acute rehabilitation stay.
- Diagnosis of depression. Active substance abuse.
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 auricular vagus active nerve stimulationIn the active stimulation, two electrodes are placed in the cymba conchae of one of the ears, an area thought to be exclusively innervated by the auricular branch of the vagus nerve. | Device | Transcutaneous auricular vagus nerve stimulation |
| Transcutaneous auricular vagus sham nerve stimulationIn the sham stimulation, the electrodes are placed on the tail of helix, which is free of vagal innervation. | Device | Sham Transcutaneous auricular vagus nerve stimulation |
Primary outcome
N-Back Computerized Task
Time frame: 15 minutes
In the n-back task, participants are presented a series of visual stimuli. They are asked for each stimulus whether it 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 trial n - 2. We will use a computerized version of this task.
Trail Making Test - Parts A & B
Time frame: 5 minutes
Trail Making Part A requires participants to draw a line between circles containing numbers in ascending order (e.g., 1-2- 3...etc.). Part B requires participants to alternate drawing a line between ascending letters and numbers (e.g., 1-A-2-B...etc.). The key measures are the time required to complete and the number of errors made in Part A and Part B. This test measures various aspects of cognition including attention, visual search, motor coordination, reasoning, and task-switching.
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 25 Mar 2025.
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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.
Shira Cohen-Zimerman, PhD principal investigator
Shirley Ryan AbilityLab
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 auricular vagus active nerve stimulation in people with 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Mar 2025. 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?
Contact Shira Cohen-Zimerman, PhD (3122386450, sohenzime@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-Back Computerized Task (time frame: 15 minutes). 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 25 Mar 2025.