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Spinal Cord Stimulation for Orthostatic Hypotension

NCT05230147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-05

No results posted yet for this study

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.

Conditions

  • Orthostatic Hypotension

Interventions

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.

PROCEDURE

Sham stimulation

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Evgeny N Mikhaylov, Assoc.prof. · Almazov National Medical Research Centre

  • Evgeny V Shlyakhto, Prof · Almazov National Medical Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2023-07-01
Completion
2024-03-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230147 on ClinicalTrials.gov