Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV

Part of paid clinical trials in Decatur, Georgia.

Sponsor
Emory University
Study ID
NCT02560805
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Microneurography — PROCEDURE
    Skin will be stimulated with a pencil-shaped electrode to find a certain nerve. Once the nerve is found, two tiny sterile wire needles (about the size of acupuncture needles) will be put in the skin. One needle is put just under the skin at a short distance away from the nerve, and the other one into the nerve. The needles are attached to a computer recorder to record the nerve activity. It may take up to one hour to get the needles in the right place. After the tiny needle is in the right place, investigators record nerve activity at rest for about 10 minutes. Then, it will be recorded throughout the rest of the visit (up to 4 hours).
  • Combat virtual reality video clip — BEHAVIORAL
    Subjects will watch a video clip of combat on a computer screen or wearing video goggles.
  • Handgrip Exercise — PROCEDURE
    Subjects will squeeze a hand dynamometer intermittently.
  • Cold Pressor Test (CPT) — PROCEDURE
    Subjects' hand will be submerged in cold water (\~0-1°C) up to the wrist for 1 minute.
  • Sodium Nitroprusside (SNP) — DRUG
    Subjects will receive sodium nitroprusside 100 µg, which is bolused through an antecubital intravenous catheter.
  • Phenylephrine — DRUG
    Subjects will receive phenylephrine 150 µg, which is bolused through an antecubital intravenous catheter 60 seconds after the sodium nitroprusside bolus
  • Losartan — DRUG
    Losartan will be administered as 25 mg taken orally, once a day for to 8 to 14 weeks.
  • Atenolol — DRUG
    Atenolol will be administered as 25 mg taken orally, once a day for to 8 to 14 weeks.
  • Transcutaneous Vagal Nerve Stimulation (tVNS) — DEVICE
    Transcutaneous vagal nerve stimulation (tVNS) is administered using the gammaCore (ElectroCore) TENS device. The gammaCore device is a multi-use, hand-held, rechargeable portable device consisting of a rechargeable battery, signal generating and amplifying electronics, and two buttons to power on the device and for operator control of the stimulation intensity (range 0-40). A small amount of conductive gel is applied to the pair of stainless steel round discs on the device are placed vertically on the skin with the gel. The stimulation is increased until there is a strong vibration and slight muscle contraction in the lower face or neck (usual intensity 15-25). Then the dose is delivered for 2 minutes on the left side of the neck, and on the right side of the neck, for a total of 4 minutes of treatment. Participants will be instructed on the usage of the device and will self-administer up to 4 treatments twice per day.
  • Sham Transcutaneous Vagal Nerve Stimulation (tVNS) — DEVICE
    A sham device that is identical to the gammaCore device will be provided to participants. Participants will be instructed on the usage of the device and will self-administer up to 4 treatments twice per day.

Study Details

The purpose of this study is to find out why patients with post-traumatic stress disorder (PTSD) have an increased risk for heart disease and high blood pressure later in life. A second purpose is to find out what causes PTSD patients to have high adrenaline levels during stress. This study will also test if a medicine called losartan improves high adrenaline levels in patients with PTSD and if a certain gene that has to do with high blood pressure might be associated with high adrenaline levels.

Key Dates

Start date
Oct 31, 2015
Status verified
May 2026
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Veterans with Post-traumatic Stress Disorder (PTSD)
    For examining Objective 1 of this study, participants with post-traumatic stress disorder (PTSD) will be evaluated using microneurography, static handgrip exercise, cold pressor test, combat virtual reality video clip, and baroreflex sensitivity using sodium nitroprusside and phenylephrine. For the second phase, they will be randomized to either losartan or atenolol.
  • Experimental: Control
    For examining Objective 1 of this study, healthy controls will be evaluated using microneurography, static handgrip exercise, cold pressor test, combat virtual reality video clip, and baroreflex sensitivity using sodium nitroprusside and phenylephrine.
  • Experimental: Losartan
    Participants with PTSD randomized to receive losartan for 8 to 14 weeks.
  • Active Comparator: Atenolol
    Participants with PTSD randomized to receive atenolol for 8 to 14 weeks.
  • Experimental: Transcutaneous Vagal Nerve Stimulation (tVNS)
    Participants with PTSD randomized to receive treatment with tVNS for 8 to 14 weeks.
  • Sham Comparator: Sham Transcutaneous Vagal Nerve Stimulation (tVNS)
    Participants with PTSD randomized to receive treatment with sham-tVNS for 8 to 14 weeks.

Primary Outcome Measure

Change in Muscle Sympathetic Nerve Activity (MSNA) [ Time Frame: Baseline, after study intervention (up to 14 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical CenterDecaturGeorgia30033-

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Atlanta VA Medical Center· Decatur, GA

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