Spinal Cord InjuryNCT02983266
Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia
A study testing InTENsity MicroCombo in people with Spinal Cord Injury, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- InTENsity MicroCombo
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Willingness to participate in the study
- 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
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- 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.
Who cannot join
- 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:
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- 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:
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miami Project to Cure Paralysis/ University of Miami
Miami, Florida, 33136
About this study
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
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
- Being tested
- InTENsity MicroCombo
- Keywords
- Hyperadrenergia, Inflammatory stress
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InTENsity MicroComboDevice
An electrotherapy device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Low Hertz | Experimental | Participants will receive 10 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session.
Device: InTENsity MicroCombo Receives: Device: InTENsity MicroCombo |
| Group 1: High Hertz | Experimental | Participants will receive 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session.
Device: InTENsity MicroCombo Receives: Device: InTENsity MicroCombo |
| Group 1: Control | Sham comparator | 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 Receives: Device: InTENsity MicroCombo |
| Group 2: Pre-stressor | Experimental | 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 Receives: Device: InTENsity MicroCombo |
| Group 2: Post-stressor | Experimental | 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 Receives: Device: InTENsity MicroCombo |
| Group 2: Control | Placebo comparator | 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 Receives: Device: InTENsity MicroCombo |
| Group 3: 30 Hz | Experimental | 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 Receives: Device: InTENsity MicroCombo |
| Group 4: 30 Hz | Experimental | 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 Receives: Device: InTENsity MicroCombo |
| Group 1: Response | Experimental | 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 Receives: Device: InTENsity MicroCombo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 90 minutes post-vagal nerve stimulation
Secondary outcomes (8)
Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation
Measured by numerical heart rate in beats per minute
Measured: Baseline to 90 minutes post-vagal nerve stimulation
Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation
Measured by diastolic and systolic blood pressure (mm/Hg)
Measured: Baseline to 90 minutes post-vagal nerve stimulation
Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials
Measured by far field potentials from the brain stem
Measured: Baseline to 90 minutes post-vagal nerve stimulation
Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol
Measured by cortisol levels in plasma
Measured: Baseline to 90 minutes post-experimental stimulus
Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines
Measured by catecholamine levels in plasma
Measured: Baseline to 90 minutes post-experimental stimulus
Group 2 & 4: Change in acute physiological stress response by a change in heart rate
Measured by numerical heart rate in beats per minute
Measured: Baseline to 90 minutes post-experimental stimulus
Group 2 & 4: Change in acute physiological stress response by a change in blood pressure
Measured by diastolic and systolic blood pressure (mm/Hg)
Measured: Baseline to 90 minutes post-experimental stimulus
Group 3 & 4: Change in inflammatory biomarkers after vagal nerve stimulation
Measured by cytokine levels in plasma
Measured: Baseline to 90 minutes post-vagal nerve stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start1 Dec 2018 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark S. Nash, Ph.D., FACSM, University of Miami
- Investigators
- Mark S Nash, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983266
- Sponsor's protocol ID
- 20150478
- Status last verified
- Oct 2018
- First submitted
- 18 Nov 2016
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02983266
- Acronym / sponsor ID
- 20150478
- Conditions
- Spinal Cord Injury
- Keywords
- Hyperadrenergia, Inflammatory stress
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Group 1: Low Hertz | Experimental | Device: InTENsity MicroComboParticipants will receive 10 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Device: InTENsity MicroCombo |
| Group 1: High Hertz | Experimental | Device: InTENsity MicroComboParticipants 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: Control | Sham comparator | Device: InTENsity MicroComboParticipants 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 2: Pre-stressor | Experimental | Device: InTENsity MicroComboParticipants 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: Post-stressor | Experimental | Device: InTENsity MicroComboParticipants 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 2: Control | Placebo comparator | Device: InTENsity MicroComboParticipants 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 | Experimental | Device: InTENsity MicroComboParticipants 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 4: 30 Hz | Experimental | Device: InTENsity MicroComboParticipants 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: Response | Experimental | Device: InTENsity MicroComboParticipants 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-65
- Willingness to participate in the study
- Age 18-65
- Overweight, with a BMI ≥ 27
- Presence of chronic inflammation, with C-reactive protein values > 3 mg/l
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InTENsity MicroComboAn electrotherapy device. | Device | Group 1: Control, Group 1: High Hertz, Group 1: Low Hertz, Group 1: Response, Group 2: Control, Group 2: Post-stressor, Group 2: Pre-stressor, Group 3: 30 Hz, Group 4: 30 Hz |
Primary outcome
Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability
Time frame: Baseline to 90 minutes post-vagal nerve stimulation
Measured by the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG)
8 secondary outcomes
Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation
Time frame: Baseline to 90 minutes post-vagal nerve stimulation
Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation
Time frame: Baseline to 90 minutes post-vagal nerve stimulation
Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials
Time frame: Baseline to 90 minutes post-vagal nerve stimulation
Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol
Time frame: Baseline to 90 minutes post-experimental stimulus
Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines
Time frame: Baseline to 90 minutes post-experimental stimulus
Group 2 & 4: Change in acute physiological stress response by a change in heart rate
Time frame: Baseline to 90 minutes post-experimental stimulus
Group 2 & 4: Change in acute physiological stress response by a change in blood pressure
Time frame: Baseline to 90 minutes post-experimental stimulus
Group 3 & 4: Change in inflammatory biomarkers after vagal nerve stimulation
Time frame: Baseline to 90 minutes post-vagal nerve stimulation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Nash, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InTENsity MicroCombo in people with Spinal Cord Injury, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability (time frame: Baseline to 90 minutes post-vagal nerve stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.