Back to resultsSpinal Cord Stimulation for Orthostatic Hypotension
Primary Purpose
Orthostatic Hypotension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Spinal cord stimulation
Sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Orthostatic Hypotension focused on measuring spinal cord stimulation, hypotension, hemodynamic effects
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Almazov National Medical Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Spinal cord stimulation
Sham stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05230147
First Posted
January 28, 2022
Last Updated
March 18, 2022
Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
1. Study Identification
Unique Protocol Identification Number
NCT05230147
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 25, 2022 (Anticipated)
Primary Completion Date
April 28, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
Keywords
spinal cord stimulation, hypotension, hemodynamic effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
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.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spinal cord stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal cord stimulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham stimulation
Intervention Description
Single stimuli are delivered to define the stimulation threshold. High-frequency stimulation is not delivered.
Primary Outcome Measure Information:
Title
Systolic blood pressure drop correction
Description
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).
Time Frame
5-30 minutes following verticalization
Secondary Outcome Measure Information:
Title
Diastolic blood pressure drop correction
Description
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).
Time Frame
5-30 minutes following verticalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny N Mikhaylov, Assoc.prof.
Phone
+7(812)7025164
Email
e.mikhaylov@almazovcentre.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny N Mikhaylov, Assoc.prof.
Organizational Affiliation
Almazov National Medical Research Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evgeny V Shlyakhto, Prof
Organizational Affiliation
Almazov National Medical Research Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Almazov National Medical Research Centre
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be discussed during regular meetings of the study and supervising committees after enrollment of at least 30% of subjects.
Citations:
PubMed Identifier
32378161
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.
Results Reference
background
PubMed Identifier
31197588
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.
Results Reference
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PubMed Identifier
28967294
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.
Results Reference
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Spinal Cord Stimulation for Orthostatic Hypotension
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