Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

NCT06589362 | Recruiting FDA Device

• 1 other identifier: STU00221084
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• N-Back Computerized Task

  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.

  15 minutes

• Trail Making Test - Parts A & B

  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.

  5 minutes

Study Arms (2)

Transcutaneous auricular vagus nerve stimulation

ACTIVE COMPARATOR

Active vagus nerve stimulation.

Device: Transcutaneous auricular vagus active nerve stimulation

Sham Transcutaneous auricular vagus nerve stimulation

SHAM COMPARATOR

Sham vagus nerve stimulation.

Device: Transcutaneous auricular vagus sham nerve stimulation

Interventions

Transcutaneous auricular vagus active nerve stimulation DEVICE

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.

Transcutaneous auricular vagus nerve stimulation

Transcutaneous auricular vagus sham nerve stimulation DEVICE

In the sham stimulation, the electrodes are placed on the tail of helix, which is free of vagal innervation.

Sham Transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60610, United States

RECRUITING

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 Officials

• Shira Cohen-Zimerman, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shira Cohen-Zimerman, PhD

CONTACT

3122386450; sohenzime@sralab.org

Katy Magee, M.H.S

CONTACT

3122386451; kmagee02@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, PhD

Model Details: a single-blind sham-controlled randomized crossover pilot study

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 7, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

US (1)