Healthy subjects and patients with autonomic dysfunction Neurovascular compression, Neurogenic hypertension, Dysautonomia
Conditions
Interventions
Group 1: Suction at the neck = 0 mmHg
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Interventional, controlled, randomized, open study. In N-of-1 studies, all measurement results originate from the same person. The number of intervention repe
Sponsors
DLR Deutsches Zentrum für Luft- und Raumfahrt
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Healthy subjects: Age = 18 years. === Patients: Age = 18 years, suspected neurovascular compression of the medulla near the root entry zone of the vagal nerve or autonomic dysfunction.
Exclusion criteria
Exclusion criteria: - Positive urine pregnancy test in women of childbearing age (premenopausal) - Previous surgery or radiation in the carotid sinus region - Afferent baroreflex failure - Atrial fibrillation - Valvular heart disease - Carotid atherosclerosis with >50% stenosis cannot be ruled out by ultrasound - MR exclusion criteria - Metal implants or other osteosynthesis material, stents, clips etc., that are not MRI compatible or hinder examinations due t- their location - Pacemaker, infusion pump, neuro-stimulator, inner ear implant - Claustrophobia - Permanent make up or tattoos which are not suitable for MRI - Piercings that cannot be removed - Current diseases of vital organs or central nervous system - Psychiatric disorders which may hinder subjects in consenting or complying with the protocol - Regular use of medicines with influence on the outcome of the study (hormonal contraceptives are no exclusion criteria) - Regular consumption of alcohol (20-30 g/day) or drugs - Blood donation within 3 months for women and 2 months for men before the study - Clinically relevant findings in the ECG such as a second- or third-degree AV block, prolongation of the QRS complex over 120 ms or of the QTc-interval over 450 ms - Supine hypertension (> 140/90 mmHg) or hypotension (< 90/50 mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the BOLD (blood oxygenation level dependent) signal intensity of medullary and hypothalamic nuclei involved in cardiovascular control. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in arterial blood pressure and heart rate. These parameters are also used as safety measures and are monitored during the experiments. Change in functional connectivity between nuclei. | — |
Countries
Germany
Contacts
Public ContactKarsten Heusser
DLR Deutsches Zentrum für Luft- und Raumfahrt
Outcome results
None listed