Recruiting

Vagal Nerve Stimulation & Cognitive Rehabilitation

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06589362

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcutaneous auricular vagus active nerve stimulation

Transcutaneous auricular vagus sham nerve stimulation

Study Details

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

Study ID

NCT06589362

Start date

Sep 7, 2024

Status verified date

Mar, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Transcutaneous auricular vagus nerve stimulation

Active vagus nerve stimulation.

sham comparator: Sham Transcutaneous auricular vagus nerve stimulation

Sham vagus nerve stimulation.

Interventions

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.

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 measure

  • N-Back Computerized Task [ Time Frame: 15 minutes ]
  • Trail Making Test - Parts A & B [ Time Frame: 5 minutes ]

Central Contacts and Locations

Central contacts

Shira Cohen-Zimerman, PhD

3122386450sohenzime@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60610

Contacts

Katy Magee, M.H.S. SLP

312-238-6451kmagee02@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Mar 25, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2025-03-25.