Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia

Spinal Cord Injury Clinical Trial

Official title:

A Study of Safety and Autonomic Responses to Non-Invasive Vagal Stimulation in Persons With Spinal Cord Injury and Non-Disabled Controls Both With and Without Inflammatory Stress

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02983266
• Other study ID #: 20150478
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Group 1 & 2:

Inclusion Criteria:

1. Age 18-65

2. 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:

Inclusion Criteria:

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

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)

6. Use of statin drugs

Group 4:

Inclusion Criteria:

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. 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)

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• InTENsity MicroCombo
An electrotherapy device.

Locations

Country	Name	City	State
United States	The Miami Project to Cure Paralysis/ University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability	Measured by the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG)	Baseline to 90 minutes post-vagal nerve stimulation
Secondary	Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation	Measured by numerical heart rate in beats per minute	Baseline to 90 minutes post-vagal nerve stimulation
Secondary	Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation	Measured by diastolic and systolic blood pressure (mm/Hg)	Baseline to 90 minutes post-vagal nerve stimulation
Secondary	Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials	Measured by far field potentials from the brain stem	Baseline to 90 minutes post-vagal nerve stimulation
Secondary	Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol	Measured by cortisol levels in plasma	Baseline to 90 minutes post-experimental stimulus
Secondary	Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines	Measured by catecholamine levels in plasma	Baseline to 90 minutes post-experimental stimulus
Secondary	Group 2 & 4: Change in acute physiological stress response by a change in heart rate	Measured by numerical heart rate in beats per minute	Baseline to 90 minutes post-experimental stimulus
Secondary	Group 2 & 4: Change in acute physiological stress response by a change in blood pressure	Measured by diastolic and systolic blood pressure (mm/Hg)	Baseline to 90 minutes post-experimental stimulus
Secondary	Group 3 & 4: Change in inflammatory biomarkers after vagal nerve stimulation	Measured by cytokine levels in plasma	Baseline to 90 minutes post-vagal nerve stimulation