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

This study is currently recruiting participants.
Verified February 2014 by Swiss Paraplegic Centre Nottwil
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01891110
First received: June 4, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Spinal Cord Injury
Orthostatic Hypotension
Procedure: ES of the abdominal muscles
Procedure: ES of the limb muscles
Procedure: ES of limbs & abdomen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI

Resource links provided by NLM:


Further study details as provided by Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • blood pressure [mmHg] [ Time Frame: 1 day (single measurement at each arm ) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: 1 day (single measurement at each arm ) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891110

Contacts
Contact: Aurelio Tobon, MD +41419395885 aurelio.tobon@paraplegie.ch
Contact: Stefanie Tesini +41419395962 stefanie.tesini@paraplegie.ch

Locations
Switzerland
Swiss Paraplegic Center Recruiting
Nottwil, Luzern, Switzerland, 6207
Contact: Aurelio Tobon, MD    +41419395885    aurelio.tobon@paraplegie.ch   
Principal Investigator: Aurelio Tobon, MD         
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Aurelio Tobon, MD Swiss paraplegic center
  More Information

Additional Information:
No publications provided

Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01891110     History of Changes
Other Study ID Numbers: ST_001
Study First Received: June 4, 2013
Last Updated: February 7, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Paraplegic Centre Nottwil:
electric stimulation
tilt-table

Additional relevant MeSH terms:
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Hypotension, Orthostatic
Spinal Cord Injuries
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 15, 2014