NCT06589362 · Shirley Ryan AbilityLab
Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation
What this study is about
The purpose of this study is to examine the feasibility and preliminary effectiveness of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).
View original scientific description
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).
Interventions
DEVICE
Transcutaneous auricular vagus active nerve stimulation
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.
DEVICE
Transcutaneous auricular vagus sham nerve stimulation
In the sham stimulation, the electrodes are placed on the tail of helix, which is free of vagal innervation.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Chicago, Illinois
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2025 · Source of record for eligibility and locations