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

NCT07428980 | Completed FDA Device

• 1 other identifier: STU00225204
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

TBI Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Vagus Nerve; Executive Functions; Transcutaneous Vagus Nerve Stimulation (tVNS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• N-Back task

  Day 0 Baseline and Day 15 Post Stimulation Assessment

• California Verbal Learning Test

  Day 0 Baseline and Day 15 Post Stimulation Assessment

• Trail Making Test A&B

  Day 0 Baseline and Day 15 Post Stimulation Assessment

Study Arms (1)

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.

Device: Transcutaneous Vagus Nerve Stimulation (tVNS)

Interventions

Transcutaneous Vagus Nerve Stimulation (tVNS) DEVICE

tVNS stimulation, one hour a day, for 14 days.

Also known as: Transcutaneous auricular vagus nerve stimulation (taVNS)

Active Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 24, 2026
• Study Start: January 9, 2026
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)