Prevention of Complications Due to Autonomic Dysreflexia in SCI Individuals

NCT ID: NCT05024487

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Autonomic Dysreflexia; Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Clinical Examination

Intervention Type: DIAGNOSTIC_TEST

Given the most frequent causes of AD, the above-mentioned trigger stimuli will be used. All these procedures are commonly used in SCI people.

Interventions

Clinical Examination

Given the most frequent causes of AD, the above-mentioned trigger stimuli will be used. All these procedures are commonly used in SCI people.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assoc. Prof. Jiri Kriz, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Assoc. Prof. Jiri Kriz, MD, PhD

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jiri Kriz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Spinal Cord Unit, University Hospital Motol

Locations

Department of Rehabilitation and Sports Medicine, University Hospital Motol

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jiri Kriz, MD, PhD

Role: CONTACT

jiri.kriz@fnmotol.cz

+420224439207

Renata Hakova, MD

Role: CONTACT

renata.hakova@fnmotol.cz

+420224439265

Facility Contacts

Pavel Kolar, Prof

Role: primary

pavel.kolar@lfmotol.cuni.cz

+420224439201

References

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.

Reference Type: BACKGROUND

PMID: 26707873 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24621047 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24343054 (View on PubMed)

Other Identifiers

SCI_DYSREFLEXIA_2021

Identifier Type: -

Identifier Source: org_study_id