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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal cord stimulation | Experimental | Before tilt testing, adhesive patches are applied to subjects' back skin. Single stimuli are delivered to the patches in order to define the stimulation threshold under the guidance of neuromyography. An investigator says loudly: "I am initiating high-frequency stimulation". Stimulation is initiated within 2 min before tilting the table. Then verticalization of the table 45 degrees is performed, and the test is continued for 15-30 min. Beat-to-beat blood pressure recording is carried out and 10 min after blood pressure complete stabilization the test is ended. |
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| Sham stimulation | Sham Comparator | Before tilt testing, adhesive patches are applied to subjects' back skin. Single stimuli are delivered to the patches in order to define stimulation threshold under the guidance of neuromyography. An investigator says loudly: "I am initiating high-frequency stimulation". No stimulation is initiated. Two minutes after, verticalization of the table 45 degrees is performed, and the test is continued for 15-30 min. Beat-to-beat blood pressure recording is carried out and 10 min after blood pressure complete stabilization the test is ended. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal cord stimulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure drop correction | 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). | 5-30 minutes following verticalization |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic blood pressure drop correction | 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). | 5-30 minutes following verticalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evgeny N Mikhaylov, Assoc.prof. | Almazov National Medical Research Centre | Principal Investigator |
| Evgeny V Shlyakhto, Prof | Almazov National Medical Research Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almazov National Medical Research Centre | Saint Petersburg | 197341 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32378161 | Background | 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. | |
| 31197588 |
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Data sharing will be discussed during regular meetings of the study and supervising committees after enrollment of at least 30% of subjects.
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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).
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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.
| Sham stimulation | Procedure | Single stimuli are delivered to define the stimulation threshold. High-frequency stimulation is not delivered. |
|
| 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. |
| 28967294 | Background | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |