Noninvasive Brain Stimulation to Enhance Cognition at Home Following a TBI.

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).

Study Overview

• Status: Completed
• Conditions: TBI Traumatic Brain Injury
• Intervention / Treatment: Device: Transcutaneous Vagus Nerve Stimulation (tVNS)

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
  • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Stimulation; 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.	Device: Transcutaneous Vagus Nerve Stimulation (tVNS); tVNS stimulation, one hour a day, for 14 days.; Other Names: Transcutaneous auricular vagus nerve stimulation (taVNS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Day 0 and Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Day 0 Baseline and Day 15 Post Stimulation Assessment

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Actual): April 27, 2026
• Study Completion (Actual): April 27, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Executive Functions; Vagus Nerve; Transcutaneous Vagus Nerve Stimulation (tVNS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: STU00225204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No