Spinal Cord InjuryNCT01891110
Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
A study testing ES of the abdominal muscles, ES of the limb muscles and ES of limbs & abdomen in people with Spinal Cord Injury and Orthostatic Hypotension, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Orthostatic Hypotension
- What is being tested?
- ES of the abdominal muscles, ES of the limb muscles and ES of limbs & abdomen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inpatients
- positive diagnosis of OH
- acute traumatic SCI
- lesion level above T6
- AIS A, B or C
Who cannot join
- fractures of the lower limbs
- decubitus (NPUAP >2)
- massive psychiatric dysfunction
- suicide intention
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Center
Nottwil, Canton of Lucerne, 6207
About this study
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.
Read more
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:
- 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
- Conditions
- Spinal Cord Injury, Orthostatic Hypotension
- Being tested
- ES of the abdominal muscles, ES of the limb muscles, ES of limbs & abdomen
- Keywords
- electric stimulation, tilt-table
- Medical subject headings
- Spinal Cord Injuries, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES of the abdominal musclesProcedure or surgery
ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
ES of the limb musclesProcedure or surgery
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 & abdomenProcedure or surgery
The combination of the ES of the lower limb muscles and the abdominal muscles.
| Study group | Role | What they receive |
|---|---|---|
| ES of the abdominal muscles | Experimental | ES with surface electrodes, fixed stimulation parameters and individual mA Receives: Procedure: ES of the abdominal muscles |
| ES of limbs & abdomen | Experimental | The combination of the ES of the lower limb muscles and the abdominal muscles. Receives: Procedure: ES of limbs & abdomen |
| ES of the limb muscles | Experimental | 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 Receives: Procedure: ES of the limb muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure [mmHg]
Measured: 1 day (single measurement at each arm )
Secondary outcomes (1)
Heart rate
Measured: 1 day (single measurement at each arm )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Aurelio Tobon, MD, Principal investigator, Swiss paraplegic center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891110
- Sponsor's protocol ID
- 2011-26
- Status last verified
- May 2014
- First submitted
- 4 Jun 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
- ClinicalTrials.gov ID
- NCT01891110
- Acronym / sponsor ID
- 2011-26
- Conditions
- Spinal Cord Injury, Orthostatic Hypotension
- Keywords
- electric stimulation, tilt-table
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ES of the abdominal muscles | Experimental | Procedure: ES of the abdominal musclesES with surface electrodes, fixed stimulation parameters and individual mA |
| ES of limbs & abdomen | Experimental | Procedure: ES of limbs & abdomenThe combination of the ES of the lower limb muscles and the abdominal muscles. |
| ES of the limb muscles | Experimental | Procedure: ES of the limb musclesLower 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- inpatients
- positive diagnosis of OH
- acute traumatic SCI
- lesion level above T6
- AIS A, B or C
Key exclusion criteria (4 listed)
- fractures of the lower limbs
- decubitus (NPUAP >2)
- massive psychiatric dysfunction
- suicide intention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ES of the abdominal musclesES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility. | Procedure or surgery | ES of the abdominal muscles |
| ES of the limb musclesLower 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 or surgery | ES of the limb muscles |
| ES of limbs & abdomenThe combination of the ES of the lower limb muscles and the abdominal muscles. | Procedure or surgery | ES of limbs & abdomen |
Primary outcome
blood pressure [mmHg]
Time frame: 1 day (single measurement at each arm )
1 secondary outcome
Heart rate
Time frame: 1 day (single measurement at each arm )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
- Swiss Paraplegic Centre NottwilLink provided by the sponsor.
Related trials for Spinal Cord Injury
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelio Tobon, MD principal investigator
Swiss paraplegic center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ES of the abdominal muscles, ES of the limb muscles and ES of limbs & abdomen in people with Spinal Cord Injury and Orthostatic Hypotension, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure [mmHg] (time frame: 1 day (single measurement at each arm )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.