Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation
NCT ID: NCT06589362
Last Updated: 2025-03-25
Study Results
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-09-07
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Transcutaneous auricular vagus nerve stimulation
Active vagus nerve stimulation.
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.
Sham Transcutaneous auricular vagus nerve stimulation
Sham vagus nerve stimulation.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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 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.
18 Years
65 Years
ALL
No
Sponsors
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Shirley Ryan AbilityLab
OTHER
Responsible Party
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Shira Cohen-Zimerman
Research Scientist, PhD
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00221084
Identifier Type: -
Identifier Source: org_study_id
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