Skip to main content
OpenTrials
Completed

NCT Number: NCT05230147

Spinal Cord Stimulation for Orthostatic Hypotension

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthostatic Hypotension Autonomic Nervous System Diseases Cardiovascular Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sham stimulation

Procedure

Single stimuli are delivered to define the stimulation threshold. High-frequency stimulation is not delivered.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 8, 2022
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.