Study on Sympathetic Overactivity in PTSD
This study is investigating whether two different device-based therapies can help veterans with Post-traumatic Stress Disorder (PTSD) and prehypertension (blood pressure that is higher than normal but not yet high blood pressure). The therapies being tested are Device-Guided Breathing (DGB) using the RESPeRATE device, and Transcutaneous Vagal Nerve Stimulation (tVNS), which uses mild electrical stimulation on the neck. Researchers want to see if 8 weeks of daily use of these devices can improve the overactivity of the sympathetic nervous system (the part of your body that controls your 'fight or flight' response) both at rest and during stress. You may be able to join if you are a veteran between 18 and 65 years old with or without PTSD, and have prehypertension or normal blood pressure. The study will measure changes in your nerve activity and how your body responds to blood pressure changes to see if these treatments are successful. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 120 participants. It compares Device-Guided Breathing and Transcutaneous Vagal Nerve Stimulation to sham (inactive) versions of these devices.
- What's involved
- Participants will use a device for 15 minutes daily (DGB) or twice daily (tVNS) for 8 weeks. Measurements of nerve activity and blood pressure response will be taken at the beginning and end of the 8-week period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed for changes in nerve activity and baroreflex sensitivity at Week 8.
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Sympathetic Overactivity in Post-traumatic Stress Disorder
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jeanie Park, MD · PRINCIPAL_INVESTIGATOR · Emory University and the Atlanta VA Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency at RestBaseline, Week 8
MSNA is assessed with microneurography where a tungsten microelectrode inserted in the nerve records sympathetic nerve activity.
- Change in Baroreflex Sensitivity (BRS) at RestBaseline, Week 8
Arterial baroreflex sensitivity (BRS) will be tested using pharmacologic manipulation of blood pressure at rest. BRS is assessed by measuring changes in MSNA and heart rate during arterial blood pressure changes induced by nitroprusside and phenylephrine.
- Change in MSNA Burst Frequency While Under Mental StressBaseline, Week 8
Mental stress will be induced by having participants complete mental arithmetic and with a combat virtual reality clip.
- Change in BRS While Under Mental StressBaseline, Week 8
Mental stress will be induced by having participants complete mental arithmetic and with a combat virtual reality clip. Arterial baroreflex sensitivity (BRS) will be tested using pharmacologic manipulation of blood pressure at rest and during mental stress.