Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia
- Conditions
- Spinal Cord Injury
- Interventions
- Device: InTENsity MicroCombo
- Registration Number
- NCT02983266
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age 18-65
- Willingness to participate in the study
- Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
- Use of a hearing aid in the left ear
- Use of an implanted insulin or morphine (pain) pump
- Self-reported history of syncope from known or unknown origins
- Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
Group 3:
Inclusion Criteria:
- Age 18-65
- Overweight, with a BMI ≥ 27
- Presence of chronic inflammation, with C-reactive protein values > 3 mg/l
- Willingness to participate in the study
Exclusion Criteria:
- Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
- Use of a hearing aid in the left ear
- Use of an implanted insulin or morphine (pain) pump
- Self-reported history of syncope from known or unknown origins
- Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
- Use of statin drugs
Group 4:
Inclusion Criteria:
- Age 18-65
- ≥ 1-year post-injury
- Bladder management by clean intermittent catheterization
- 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.
- 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.
- Willingness to participate in the study.
Exclusion Criteria:
- Currently hospitalized
- American Spinal Injury Association (AIS) C-E
- Currently using an insulin, morphine (pain), or intrathecal pump
- Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
- Use of a hearing aid in the left ear
- Self-reported history of syncope from known or unknown origins
- Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4: 30 Hz InTENsity MicroCombo 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 1: Control InTENsity MicroCombo 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 1: High Hertz InTENsity MicroCombo 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 1: Low Hertz InTENsity MicroCombo 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 2: Post-stressor InTENsity MicroCombo 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 1: Response InTENsity MicroCombo 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 2: Pre-stressor InTENsity MicroCombo 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 2: Control InTENsity MicroCombo 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 3: 30 Hz InTENsity MicroCombo 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
- Primary Outcome Measures
Name Time Method Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability Baseline to 90 minutes post-vagal nerve stimulation Measured by the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG)
- Secondary Outcome Measures
Name Time Method Group 2 & 4: Change in acute physiological stress response by a change in heart rate Baseline to 90 minutes post-experimental stimulus Measured by numerical heart rate in beats per minute
Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol Baseline to 90 minutes post-experimental stimulus Measured by cortisol levels in plasma
Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines Baseline to 90 minutes post-experimental stimulus Measured by catecholamine levels in plasma
Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation Baseline to 90 minutes post-vagal nerve stimulation Measured by diastolic and systolic blood pressure (mm/Hg)
Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials Baseline to 90 minutes post-vagal nerve stimulation Measured by far field potentials from the brain stem
Group 3 & 4: Change in inflammatory biomarkers after vagal nerve stimulation Baseline to 90 minutes post-vagal nerve stimulation Measured by cytokine levels in plasma
Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation Baseline to 90 minutes post-vagal nerve stimulation Measured by numerical heart rate in beats per minute
Group 2 & 4: Change in acute physiological stress response by a change in blood pressure Baseline to 90 minutes post-experimental stimulus Measured by diastolic and systolic blood pressure (mm/Hg)
Trial Locations
- Locations (1)
The Miami Project to Cure Paralysis/ University of Miami
🇺🇸Miami, Florida, United States