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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891110
• Other study ID #: 2011-26
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: May 13, 2014
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Procedure:
• ES of the abdominal muscles
ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
• 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
• ES of limbs & abdomen
The combination of the ES of the lower limb muscles and the abdominal muscles.

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Center	Nottwil	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure [mmHg]		1 day (single measurement at each arm )	No
Secondary	Heart rate		1 day (single measurement at each arm )	No

External Links

•   Swiss Paraplegic Centre Nottwil