Clinical trial NCT05230147: Spinal Cord Stimulation for Orthostatic Hypotension
Official title: Hemodynamic Effects of Transcutaneous Spinal Cord Stimulation During Passive Orthostasis: a Prospective Single-center Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthostatic Hypotension
Keywords: spinal cord stimulation
hypotension
hemodynamic effects
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Systolic blood pressure drop correction
timeFrame: 5-30 minutes following verticalization
Secondary outcomes:
measure: Diastolic blood pressure drop correction
timeFrame: 5-30 minutes following verticalization
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
Study officials:
affiliation: Almazov National Medical Research Centre
name: Evgeny N Mikhaylov, Assoc.prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Almazov National Medical Research Centre
name: Evgeny V Shlyakhto, Prof
role: STUDY_CHAIR
References:
citation: Mikhaylov EN, Moshonkina TR, Zharova EN, Garkina SV, Kovzelev PD, Belyaeva NN, Kozlenok AV, Lebedev DS, Shlyakhto EV. Acute Cardiovascular Effects of Non-Invasive Electrical Spinal Cord Stimulation: Results from a Pilot Study in Humans. J Cardiovasc Transl Res. 2020 Dec;13(6):891-893. doi: 10.1007/s12265-020-10014-7. Epub 2020 May 6.
citation: Lobov GI, Gerasimenko YP, Moshonkina TR. Mechanisms of Blood Flow Regulation in the Skin during Stimulation of the Spinal Cord in Humans. Dokl Biol Sci. 2019 Mar;485(1):27-29. doi: 10.1134/S0012496619020030. Epub 2019 Jun 13.
citation: Phillips AA, Squair JW, Sayenko DG, Edgerton VR, Gerasimenko Y, Krassioukov AV. An Autonomic Neuroprosthesis: Noninvasive Electrical Spinal Cord Stimulation Restores Autonomic Cardiovascular Function in Individuals with Spinal Cord Injury. J Neurotrauma. 2018 Feb 1;35(3):446-451. doi: 10.1089/neu.2017.5082. Epub 2017 Nov 21.