Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

NCT ID: NCT06589362

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-07

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

a single-blind sham-controlled randomized crossover pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Transcutaneous auricular vagus nerve stimulation

Active vagus nerve stimulation.

Group Type ACTIVE_COMPARATOR

Transcutaneous auricular vagus active nerve stimulation

Intervention Type 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.

Sham Transcutaneous auricular vagus nerve stimulation

Sham vagus nerve stimulation.

Group Type SHAM_COMPARATOR

Transcutaneous auricular vagus sham nerve stimulation

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

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Shira Cohen-Zimerman

Research Scientist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shira Cohen-Zimerman, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

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Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shira Cohen-Zimerman, PhD

Role: CONTACT

3122386450

Katy Magee, M.H.S

Role: CONTACT

3122386451

Facility Contacts

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Katy Magee, M.H.S. SLP

Role: primary

312-238-6451

Other Identifiers

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STU00221084

Identifier Type: -

Identifier Source: org_study_id

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