Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI

Background:

The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution during verticalisation in persons with spinal cord injury (SCI) is a common condition.

Aims:

To investigate the impact of three different types of electric stimulation (ES) (ES of the abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and lower limb muscles versus control) on blood pressure stabilization and verticalisation-degrees between 0° and 70°. The hypothesis is, that the ES-induced contractions of the muscles cause a stabilisation respectively an increase of the blood pressure during the tilt-table test.

Subjects:

20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C and a diagnosis of OH (by tilt table test) were eligible for the study.

Methods:

Each patient underwent randomly three different types of ES sessions while being positioned on a tilt-table. The following sessions were planned:

A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D) Control session (=diagnostic session)

Study type: Intervention Design: Prospective interventional study

Study Overview

• Status: Completed
• Conditions: Orthostatic Hypotension; Spinal Cord Injury
• Intervention / Treatment: Procedure: ES of the abdominal muscles; Procedure: ES of limbs & abdomen; Procedure: ES of the limb muscles

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Luzern
    • Nottwil, Luzern, Switzerland, 6207
      • Swiss Paraplegic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• inpatients
• positive diagnosis of OH
• acute traumatic SCI
• lesion level above T6
• AIS A, B or C

Exclusion Criteria:

• fractures of the lower limbs
• decubitus (NPUAP >2)
• massive psychiatric dysfunction
• suicide intention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ES of the abdominal muscles; ES with surface electrodes, fixed stimulation parameters and individual mA	Procedure: ES of the abdominal muscles; ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
Experimental: ES of limbs & abdomen; The combination of the ES of the lower limb muscles and the abdominal muscles.	Procedure: ES of limbs & abdomen; The combination of the ES of the lower limb muscles and the abdominal muscles.
Experimental: ES of the limb muscles; Lower limb muscles were stimulated to produce a milking mechanism from the distal to proximal part of the limb to pump the venous blood from the peripheral to the central part of the body	Procedure: ES of the limb muscles; Lower limb muscles were stimulated to produce a milking mechanism from the distal to proximal part of the limb to pump the venous blood from the peripheral to the central part of the body

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
blood pressure [mmHg]	1 day (single measurement at each arm )

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate	1 day (single measurement at each arm )

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Centre Nottwil
• Investigators: Principal Investigator: Aurelio Tobon, MD, Swiss Paraplegic Center

Publications and helpful links

Helpful Links

• Swiss Paraplegic Centre Nottwil

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 2, 2013

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: electric stimulation; tilt-table
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Hypotension; Spinal Cord Injuries; Hypotension, Orthostatic
• Other Study ID Numbers: 2011-26