Spinal Cord Stimulation for Orthostatic Hypotension

March 4, 2024 updated by: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Hemodynamic Effects of Transcutaneous Spinal Cord Stimulation During Passive Orthostasis: a Prospective Single-center Randomized Cross-over Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Saint-Petersburg, Russian Federation, 197341
        • Almazov National Medical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinal cord stimulation
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.
Procedure: Spinal 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.
Sham Comparator: Sham stimulation
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.
Procedure: Sham stimulation
Single stimuli are delivered to define the stimulation threshold. High-frequency stimulation is not delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure drop correction
Time Frame: 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).
5-30 minutes following verticalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic blood pressure drop correction
Time Frame: 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).
5-30 minutes following verticalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Investigators

  • Study Chair: Evgeny V Shlyakhto, Prof, Almazov National Medical Research Centre
  • Principal Investigator: Evgeny N Mikhaylov, Assoc.prof., Almazov National Medical Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ortho-stim_2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing will be discussed during regular meetings of the study and supervising committees after enrollment of at least 30% of subjects.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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