Orthostatic Hypotension
Conditions
Keywords
spinal cord stimulation, hypotension, hemodynamic effects
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 orthostatic hypotension.
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 an informed consent form before the procedure. Non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using modulated electrical impulses through external adhesive electrode patches connected to a neural stimulator device. The study protocol includes analysis of the following parameters: heart rate; 12-lead electrocardiogram; continuous beat-to-beat blood pressure recordings (measured noninvasively by plethysmography) before stimulation, during stimulation and after spinal cord stimulation. All registered data will be analyzed at the end of the procedure.
Interventions
PROCEDURESpinal cord stimulation
Single stimuli are delivered to define the stimulation threshold. High-frequency stimulation with modulated current via skin patches captures posterior horns of the spinal cord.
PROCEDURESham stimulation
Single stimuli are delivered to define the stimulation threshold. High-frequency stimulation is not delivered.
Sponsors
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Stimulation patches will be applied in all patients and simulating of stimulation will be provided by an audible order by an investigator. Since high-frequency stimulation is almost non-sensible, masking is possible.
Intervention model description
Patients will undergo spinal cord stimulation or a sham procedure during tilt testing following randomization. Then a second test will be performed the same day after crossover. A repeated test will be performed after 7 days in reverse order (sham or stimulation).
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-85 years 2. 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. 3. The patient who signed the informed consent form
Exclusion criteria
1. Orthostatic hypotension caused by acute hypovolemia or bleeding. 2. Chronic heart failure III-IV functional class (NYHA) 3. 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. 4. Ongoing acute illness. 5. \>90% paced cardiac rhythm. 6. Permanent atrial fibrillation. 7. A history of transient ischemic attack or stroke within 3 months before the enrollment and/or incomplete recovery. 8. Pulmonary embolism \<1 month ago. 9. Epilepsy. 10. The presence of an implantable pump. 11. Patients with contraindications to the use of the patch electrodes used in this study, as indicated in the relevant instructions for use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure drop correction | 5-30 minutes following verticalization | It is suggested that spinal cord stimulation will correct systolic blood pressure drop during tilt testing. The effect is expected within 5-10 mmHg as a difference between minimum systolic blood pressure during stimulation and without stimulation (sham). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic blood pressure drop correction | 5-30 minutes following verticalization | It is suggested that spinal cord stimulation will correct diastolic blood pressure drop during tilt testing. The effect is expected within 5-10 mmHg as a difference between minimum diastolic blood pressure during stimulation and without stimulation (sham). |
Countries
Russia
Outcome results
None listed