Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06589362

Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

Led by Shirley Ryan AbilityLab · Updated on 2025-03-25

60

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Inpatient rehabilitation patients due to recent Traumatic Brain Injury, ages 18 to 65 years
  • Ability to independently use a keyboard
  • Ability to understand and communicate in English as judged clinically
  • Ability to provide independent consent for participation
  • Orientation to place, time, and situation with two consecutive Orientation Log scores of 25 or higher
Not Eligible

You will not qualify if you...

  • Acute medical conditions requiring close physician or nursing monitoring
  • Presence of bioelectrical implants, including pacemakers
  • Pregnancy or lactation
  • Significant gross or fine motor weakness
  • Severe ongoing communication or comprehension impairments such as aphasia
  • Acute agitation or behavioral issues with an Agitated Behavior Scale Score over 21
  • Severely impaired memory retention with a 3 Word Delayed Recall test score below 3
  • Diagnosis of depression
  • Active substance abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shirley Ryan AbilityLab

Chicago, Illinois, United States, 60610

Actively Recruiting

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Research Team

S

Shira Cohen-Zimerman, PhD

CONTACT

K

Katy Magee, M.H.S

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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