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Spinal Cord Stimulation for Orthostatic Hypotension

Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05230147
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
15.2
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Spinal cord stimulation
  • Procedure: Sham stimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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).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).
Masking:
Single (Investigator)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Hemodynamic Effects of Transcutaneous Spinal Cord Stimulation During Passive Orthostasis: a Prospective Single-center Randomized Cross-over Study
Anticipated Study Start Date :
Mar 25, 2022
Anticipated Primary Completion Date :
Apr 28, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Almazov National Medical Research Centre Saint-Petersburg Russian Federation 197341

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
ClinicalTrials.gov Identifier:
NCT05230147
Other Study ID Numbers:
  • Ortho-stim_2022
First Posted:
Feb 8, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
spinal cord stimulation
hypotension
hemodynamic effects
Additional relevant MeSH terms:
Hypotension, Orthostatic
Hypotension

Study Results

No Results Posted as of Mar 31, 2022