DRKS00028622Recruiting未知
Baroreflex stimulation to localize blood pressure regulating brainstem nuclei in a single individual - NVC-NO1
DLR Deutsches Zentrum für Luft- und Raumfahrt0 sites6 target enrollmentStarted: May 30, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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
- •- 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)
Investigators
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