Spinal Cord Stimulation for Orthostatic Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-25

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Orthostatic Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Spinal cord stimulation

Intervention Type 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

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.

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Sham stimulation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No