RecruitingNot ApplicableNCT06589362

Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

Enhancing Cognitive Rehabilitation After TBI Using Noninvasive Vagal Nerve Stimulation


Sponsor

Shirley Ryan AbilityLab

Enrollment

60 participants

Start Date

Sep 7, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether a small, painless device worn on the ear — called transcutaneous auricular vagus nerve stimulation (tVNS) — can help improve thinking and executive function in people recovering from a mild to moderate traumatic brain injury (TBI) during inpatient rehabilitation. Participants attend two sessions a few days apart, receiving either active stimulation or a sham (inactive) version while completing cognitive tasks. Adults aged 18 to 65 who are in inpatient rehabilitation following a recent TBI, can use a keyboard independently, and are oriented and able to consent can join — those with pacemakers, significant communication impairments, severe agitation, or depression are not eligible. Each session lasts about the duration of the cognitive tasks, and there are no medications or invasive procedures involved. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous 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.

DEVICETranscutaneous auricular vagus sham nerve stimulation

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


Locations(1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States

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NCT06589362


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