Prevention of Complications Due to Autonomic Dysreflexia in SCI Individuals
Primary Purpose
Autonomic Dysreflexia, Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Clinical Examination
Sponsored by
About this trial
This is an interventional prevention trial for Autonomic Dysreflexia focused on measuring Autonomic Nervous System, Spinal Cord Injury, Prevention
Eligibility Criteria
Inclusion Criteria:
- 18 to 70 years old female and male patients
- People in chronic phase (more than 12 months) after traumatic or ischemic spinal cord lesion
- People with Neurological Level of Injury C3-T6 and ASIA Impairment Scale A-B according to ISNCSCI
- Written informed consent
Exclusion Criteria:
- People with acute infection or other suddenly incurred complication
Sites / Locations
- Department of Rehabilitation and Sports Medicine, University Hospital MotolRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
The correlation between blood pressure level, dermal resistance level, and subjective symptoms caused by triggered AD below the level of the lesion will be performed in a group of SCI people.
Outcomes
Primary Outcome Measures
Blood pressure monitoring
Continuous blood pressure and heart rate monitoring will be recorded using Finapres device.
The risk level will be determined according to the value of systolic blood pressure (SBP):
Low risk - SBP to 150 mmHg
Moderate risk - SBP 150-200 mmHg
High risk - SBP above 200 mmHg
Secondary Outcome Measures
Dermal sweating
Wrist sweating will be monitored using a measure of dermal resistance with range 0-5 MΩ (difference 0,1 kΩ, accuracy 0,15 %) and 5-32 MΩ (difference 10 kΩ, accuracy 1 %) and sampling frequency 10 second.
Regarding the AD symptoms, level of dermal resistance decrease corresponds to increase of sweating.
Assessment of symptoms
Subjective individual symptoms are divided into three groups, according to their severity (minimum value: mild symptoms, maximum: strong symptoms):
Mild symptoms - shivers on the nape or on the back
Moderate symptoms - sweating on the forehead, neck or upper extremities
Strong symptoms - pounding headache, nausea
ADFSCI questionnaire
The ADFSCI (Autonomic Dysfunction Following Spinal Cord Injury) questionnaire provides information about individual symptoms of blood pressure (BP) instability. The ADFSCI is a 24-item questionnaire consisting of four parts: demographics, medication, AD, and hypotension. The AD and hypotension parts include 10 and 7 items, respectively, each using a 5-point scale to score the frequency and severity of hyper- or hypotensive symptoms with a range of 0 ∼ 204 (highest BP instability) points.
Full Information
NCT ID
NCT05024487
First Posted
August 13, 2021
Last Updated
March 12, 2023
Sponsor
Assoc. Prof. Jiri Kriz, MD, PhD
1. Study Identification
Unique Protocol Identification Number
NCT05024487
Brief Title
Prevention of Complications Due to Autonomic Dysreflexia in SCI Individuals
Official Title
Risk Level Determination of Vascular Complications Due to Autonomic Dysreflexia in Spinal Cord Injured Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Assoc. Prof. Jiri Kriz, MD, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Autonomic dysreflexia (AD) is a syndrome of unbalanced response of the sympathetic system to noxious stimuli below the level of spinal cord injury (SCI), characterized by paroxysmal hypertension. Mostly, it is combined with symptoms such as pounding headache, slowed heart rate, and upper body flushing, but it can also be asymptomatic. When resulting in hypertensive crisis, it can be life-threatening and result in seizures, cardiac arrest, retinal or subarachnoid hemorrhages, stroke, and even death.
The aim of this study is to determine the risk level of vascular complications in SCI people by correlating the clinical symptoms with their individual perception during AD triggered below the level of injury.
Detailed Description
After spinal cord injury, the disruption of descending vasomotor pathways to sympathetic neurons causes their hyperexcitability. When irritated by noxious stimuli below the level of injury, a massive sympathetic reflex is triggered, causing widespread vasoconstriction. If the neurological level of injury is at or above T6, this vasoconstriction can lead to progressive hypertension possibly involving the splanchnic vessels.
In response to hypertension, the baroreflex system lowers blood pressure by reducing heart rate and decreasing the activity of sympathetic neurons. However, a decrease in peripheral vascular resistance below the injury level does not occur because of the disruption of descending vasomotor pathways to sympathetic neurons. Thus, hypertension persists until the triggering stimulus is removed. Hypertensive crises can result in vascular complications like cardiac arrest, retinal or subarachnoid hemorrhages, stroke, and even death. Vasodilatation above the lesion level is accompanied by characteristic signs and symptoms such as upper body flushing and sweating, and a pounding headache. Sometimes bradyarrhythmia, seizures, nausea, or anxiety can occur. Unfortunately, AD can take place asymptomatically in almost 40 %. These asymptomatic individuals are at high risk of life-threatening complications mentioned above.
The most frequent AD triggers are overfilled bladder or bowel. Nevertheless, it can be any irritating stimuli below the level of injury, i.e., skin lacerations, ingrown toenails, or pressure sores.
Higher intensity of perception of clinical symptoms accompanying AD decreases the risk of vascular complications. People who perceive subjective signs of AD even in slightly elevated blood pressure can eliminate irritating stimuli or use an antihypertensive medication and thus avoid life-threatening complications. On contrary, people who cannot perceive the signs intensely enough are at a significantly higher risk of vascular complications.
The aim of this study is to determine the risk level of vascular complications in SCI people. The AD will be triggered below the injury level so that the clinical symptoms can be correlated with their subjective individual perception. Moreover, the development of a method allowing capturing AD episodes in individuals without subjective signs is intended.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Dysreflexia, Spinal Cord Injuries
Keywords
Autonomic Nervous System, Spinal Cord Injury, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The correlation between blood pressure level, dermal resistance level, and subjective symptoms caused by triggered AD below the level of the lesion will be performed in a group of SCI people.
Intervention Type
Diagnostic Test
Intervention Name(s)
Clinical Examination
Other Intervention Name(s)
Pinprick in sacral dermatome 4/5 (a part of International Standards for Neurological Classification of Spinal Cord Injury - ISNCSCI), Deep Anal Pressure (a part of ISNCSCI), Intermittent catheterization of the bladder, In absence of one of above-mentioned stimuli, stretching of hamstrings during elevation of legs will be performed
Intervention Description
Given the most frequent causes of AD, the above-mentioned trigger stimuli will be used. All these procedures are commonly used in SCI people.
Primary Outcome Measure Information:
Title
Blood pressure monitoring
Description
Continuous blood pressure and heart rate monitoring will be recorded using Finapres device.
The risk level will be determined according to the value of systolic blood pressure (SBP):
Low risk - SBP to 150 mmHg
Moderate risk - SBP 150-200 mmHg
High risk - SBP above 200 mmHg
Time Frame
During the intervention
Secondary Outcome Measure Information:
Title
Dermal sweating
Description
Wrist sweating will be monitored using a measure of dermal resistance with range 0-5 MΩ (difference 0,1 kΩ, accuracy 0,15 %) and 5-32 MΩ (difference 10 kΩ, accuracy 1 %) and sampling frequency 10 second.
Regarding the AD symptoms, level of dermal resistance decrease corresponds to increase of sweating.
Time Frame
During the intervention
Title
Assessment of symptoms
Description
Subjective individual symptoms are divided into three groups, according to their severity (minimum value: mild symptoms, maximum: strong symptoms):
Mild symptoms - shivers on the nape or on the back
Moderate symptoms - sweating on the forehead, neck or upper extremities
Strong symptoms - pounding headache, nausea
Time Frame
During the intervention
Title
ADFSCI questionnaire
Description
The ADFSCI (Autonomic Dysfunction Following Spinal Cord Injury) questionnaire provides information about individual symptoms of blood pressure (BP) instability. The ADFSCI is a 24-item questionnaire consisting of four parts: demographics, medication, AD, and hypotension. The AD and hypotension parts include 10 and 7 items, respectively, each using a 5-point scale to score the frequency and severity of hyper- or hypotensive symptoms with a range of 0 ∼ 204 (highest BP instability) points.
Time Frame
During the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 70 years old female and male patients
People in chronic phase (more than 12 months) after traumatic or ischemic spinal cord lesion
People with Neurological Level of Injury C3-T6 and ASIA Impairment Scale A-B according to ISNCSCI
Written informed consent
Exclusion Criteria:
People with acute infection or other suddenly incurred complication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiri Kriz, MD, PhD
Phone
+420224439207
Email
jiri.kriz@fnmotol.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Renata Hakova, MD
Phone
+420224439265
Email
renata.hakova@fnmotol.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiri Kriz, MD, PhD
Organizational Affiliation
Spinal Cord Unit, University Hospital Motol
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation and Sports Medicine, University Hospital Motol
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Kolar, Prof
Phone
+420224439201
Email
pavel.kolar@lfmotol.cuni.cz
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26707873
Citation
Machac S, Radvansky J, Kolar P, Kriz J. Cardiovascular response to peak voluntary exercise in males with cervical spinal cord injury. J Spinal Cord Med. 2016 Jul;39(4):412-20. doi: 10.1080/10790268.2015.1126939. Epub 2015 Dec 28.
Results Reference
background
PubMed Identifier
24621047
Citation
Kriz J, Andel R, Hakova R. Delayed diagnosis of an unsuspected pelvic fracture in a patient with tetraplegia. J Spinal Cord Med. 2014 Jul;37(4):425-8. doi: 10.1179/2045772313Y.0000000178. Epub 2014 Jan 3.
Results Reference
background
PubMed Identifier
24343054
Citation
Kriz J, Relichova Z. Intermittent self-catheterization in tetraplegic patients: a 6-year experience gained in the spinal cord unit in Prague. Spinal Cord. 2014 Feb;52(2):163-6. doi: 10.1038/sc.2013.154. Epub 2013 Dec 17.
Results Reference
background
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Prevention of Complications Due to Autonomic Dysreflexia in SCI Individuals
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