Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous auricular vagus active nerve stimulation, Transcutaneous auricular vagus sham nerve stimulation.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Enhancing Cognitive Rehabilitation After TBI Using Noninvasive Vagal Nerve Stimulation
Overview
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.
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]
- Trail Making Test - Parts A & B [Time frame: 5 minutes]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Shirley Ryan AbilityLab — Chicago
Identifiers
NCT: NCT06589362 · STU00221084