Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia

NCT ID: NCT02983266

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-12-01

Brief Summary

The purpose of this research device study is to learn more about the autonomic nervous system. This system uses nerves to send information from the brain to the rest of the body by electrical signaling and has two divisions, the sympathetic and the parasympathetic branches. It has been thought that electrical stimulation devices could be used to restore balance to the nervous system. Because most of the imbalance seems to happen due to too much sympathetic activity, the investigator plans to focus on the parasympathetic branch. Specifically, the investigator hopes to restore balance by targeting the vagus nerve, which is the main communicator of the parasympathetic branch. The study will examine whether the investigator can decrease sympathetic activity and chronic inflammation by increasing parasympathetic activity. This is a device study that will examine the use of non-invasive vagal nerve stimulation to attenuate inflammatory stress and sympathetic hyperactivity in persons with Spinal Cord Injury and Non-Disabled Controls.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Group 1: Low Hertz

Participants will receive 10 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session.

Device: InTENsity MicroCombo

Group Type: EXPERIMENTAL

InTENsity MicroCombo

Intervention Type: DEVICE

An electrotherapy device.

Group 1: High Hertz

Participants will receive 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session.

Device: InTENsity MicroCombo

Group Type: EXPERIMENTAL

InTENsity MicroCombo

Intervention Type: DEVICE

An electrotherapy device.

Group 1: Control

Participants will receive 30 hertz stimulation to a non-vagally innervated region of the left ear, delivered in one 15 minute session.

Device: InTENsity MicroCombo

Group Type: SHAM_COMPARATOR

InTENsity MicroCombo

Intervention Type: DEVICE

An electrotherapy device.

Group 2: Pre-stressor

Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session prior to receiving experimental sympathetic induction.

Device: InTENsity MicroCombo

Group Type: EXPERIMENTAL

InTENsity MicroCombo

Intervention Type: DEVICE

An electrotherapy device.

Group 2: Post-stressor

Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session after experimental sympathetic induction.

Device: InTENsity MicroCombo

Group Type: EXPERIMENTAL

InTENsity MicroCombo

Intervention Type: DEVICE

An electrotherapy device.

Group 2: Control

Participants will receive 10 or 30 hertz stimulation to a non-vagally innervated region of the left ear, delivered in one 15 minute session prior to receiving experimental sympathetic induction.

Device: InTENsity MicroCombo

Group Type: PLACEBO_COMPARATOR

InTENsity MicroCombo

Intervention Type: DEVICE

An electrotherapy device.

Group 3: 30 Hz

Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session.

Device: InTENsity MicroCombo

Group Type: EXPERIMENTAL

InTENsity MicroCombo

Intervention Type: DEVICE

An electrotherapy device.

Group 4: 30 Hz

Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Participants will also receive stimulation on a subsequent session prior to urodynamic testing.

Device: InTENsity MicroCombo

Group Type: EXPERIMENTAL

InTENsity MicroCombo

Intervention Type: DEVICE

An electrotherapy device.

Group 1: Response

Participants will receive 10-30 hertz stimulation to the left auricular branch of the vagus nerve, delivered over the course of 1 hour.

Device: InTENsity MicroCombo

Group Type: EXPERIMENTAL

InTENsity MicroCombo

Intervention Type: DEVICE

An electrotherapy device.

Interventions

InTENsity MicroCombo

An electrotherapy device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18-65

2. Willingness to participate in the study

1. Age 18-65

2. Overweight, with a BMI ≥ 27

3. Presence of chronic inflammation, with C-reactive protein values > 3 mg/l

4. Willingness to participate in the study

1. Age 18-65

2. ≥ 1-year post-injury

3. Bladder management by clean intermittent catheterization

4. Spinal cord injury resulting in Paraplegia level T1 to T6 and motor-complete (AIS A or B) impairment. Injury level and impairment will be confirmed by an ASIA exam conducted less than 2 years before study entry. If longer than 2 years, we will have a certified rater repeat the exam.

5. Participant report of symptoms related to autonomic dysreflexia during episodes of full bladder or voiding, including elevated BP, mild headache, paresthesia, chills, nasal congestion, flushing of the skin, or diaphoresis.

6. Willingness to participate in the study.

Exclusion Criteria

1. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant

2. Use of a hearing aid in the left ear

3. Use of an implanted insulin or morphine (pain) pump

4. Self-reported history of syncope from known or unknown origins

5. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)

Group 3:

1. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant

2. Use of a hearing aid in the left ear

3. Use of an implanted insulin or morphine (pain) pump

4. Self-reported history of syncope from known or unknown origins

5. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)

6. Use of statin drugs

Group 4:

1. Currently hospitalized

2. American Spinal Injury Association (AIS) C-E

3. Currently using an insulin, morphine (pain), or intrathecal pump

4. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant

5. Use of a hearing aid in the left ear

6. Self-reported history of syncope from known or unknown origins

7. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Mark S. Nash, Ph.D., FACSM

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark S Nash, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

The Miami Project to Cure Paralysis/ University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20150478

Identifier Type: -

Identifier Source: org_study_id