Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Device: Transcutaneous auricular vagus active nerve stimulation; Device: Transcutaneous auricular vagus sham nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06589362

STU00221084

Details and patient eligibility

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).

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Transcutaneous auricular vagus nerve stimulation

Active Comparator group

Description:

Active vagus nerve stimulation.

Treatment:

Device: Transcutaneous auricular vagus active nerve stimulation

Sham Transcutaneous auricular vagus nerve stimulation

Sham Comparator group

Description:

Sham vagus nerve stimulation.

Treatment:

Device: Transcutaneous auricular vagus sham nerve stimulation