Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia
| Status: | Withdrawn |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/11/2018 |
| Start Date: | December 1, 2018 |
| End Date: | December 1, 2020 |
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.
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.
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)
We found this trial at
1
site
Miami, Florida 33136
Principal Investigator: Mark S Nash, Ph.D.
Phone: 305-243-6320
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