Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury
• Interventions: Device: Transcutaneous auricular vagus nerve stimulation

• Registration Number: NCT06589362
• Lead Sponsor: Shirley Ryan AbilityLab

Brief 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).

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 Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Study Start: 2024-09-07
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-06
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcutaneous auricular vagus nerve stimulation	Transcutaneous auricular vagus nerve stimulation	Active vagus nerve stimulation.
Sham Transcutaneous auricular vagus nerve stimulation	Transcutaneous auricular vagus nerve stimulation	Sham vagus nerve stimulation.

Primary Outcome Measures

Name	Time	Method
N-Back Computerized Task	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	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.

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States