Spinal Cord Stimulation for Orthostatic Hypotension

Not Applicable

Completed

• Conditions: Orthostatic Hypotension
• Interventions: Procedure: Sham stimulation; Procedure: Spinal cord stimulation

• Registration Number: NCT05230147
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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.

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-08
• Study Start: 2022-03-25
• Primary Completion: 2023-07-01
• Status Verified: 2024-03
• Study Completion: 2024-03-01
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham stimulation	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.
Spinal cord stimulation	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.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure drop correction	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 Outcome Measures

Name	Time	Method
Diastolic blood pressure drop correction	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).

Trial Locations

Locations (1)

Almazov National Medical Research Centre; 🇷🇺 Saint-Petersburg, Russian Federation