NCT05230147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

January 28, 2022

Last Update Submit

March 4, 2024

Conditions

Orthostatic Hypotension

Keywords

spinal cord stimulationhypotensionhemodynamic effects

Outcome Measures

Primary Outcomes (1)

  • 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).

    5-30 minutes following verticalization

Secondary Outcomes (1)

  • Diastolic blood pressure drop correction

    5-30 minutes following verticalization

Study Arms (2)

Spinal cord stimulation

EXPERIMENTAL

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

Sham stimulation

SHAM COMPARATOR

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

Interventions

Spinal cord stimulationPROCEDURE

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.

Spinal cord stimulation
Sham stimulationPROCEDURE

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

Sham stimulation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location

Related Publications (3)

  • 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.

    PMID: 32378161BACKGROUND

  • 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.

    PMID: 31197588BACKGROUND

  • 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.

    PMID: 28967294BACKGROUND

MeSH Terms

Conditions

Hypotension, OrthostaticHypotension

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Evgeny N Mikhaylov, Assoc.prof.

    Almazov National Medical Research Centre

    PRINCIPAL INVESTIGATOR

  • Evgeny V Shlyakhto, Prof

    Almazov National Medical Research Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 8, 2022

Study Start

March 25, 2022

Primary Completion

July 1, 2023

Study Completion

March 1, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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

Locations

RU(1)