Status:
COMPLETED
Spinal Cord Stimulation for Orthostatic Hypotension
Lead Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Conditions:
Orthostatic Hypotension
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a prospective single-center randomized crossover control study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation in patients with known or suspected orth...
Detailed Description
The hypothesis is that transcutaneous spinal cord stimulation at thoracic level may correct hypotensive episodes during tilt testing in subjects with blood pressure drops. Eligible patients will sign...
Eligibility Criteria
Inclusion
- Age 18-85 years
- Suspected orthostatic hypotension (having a history of syncope and/or pre-syncope that occurred during the transition to an upright position, with complaints of recurrent dizziness that occurs during the transition to an upright position) or documented orthostatic hypotension.
- The patient who signed the informed consent form
Exclusion
- Orthostatic hypotension caused by acute hypovolemia or bleeding.
- Chronic heart failure III-IV functional class (NYHA)
- Structural heart disease of the following: hypertrophic cardiomyopathy with obstruction of the left ventricular outflow tract, acute coronary syndrome, restrictive cardiomyopathy, hemodynamically significant valvular heart defects, uncorrected hemodynamically significant congenital heart defects.
- Ongoing acute illness.
- \>90% paced cardiac rhythm.
- Permanent atrial fibrillation.
- A history of transient ischemic attack or stroke within 3 months before the enrollment and/or incomplete recovery.
- Pulmonary embolism \<1 month ago.
- Epilepsy.
- The presence of an implantable pump.
- Patients with contraindications to the use of the patch electrodes used in this study, as indicated in the relevant instructions for use.
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05230147
Start Date
March 25 2022
End Date
March 1 2024
Last Update
March 5 2024
Active Locations (1)
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1
Almazov National Medical Research Centre
Saint Petersburg, Russia, 197341