Prevention of Complications Due to Autonomic Dysreflexia in SCI Individuals

NCT05024487 | Unknown

• 1 other identifier: SCI_DYSREFLEXIA_2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Dysreflexia; Spinal Cord Injuries

Keywords

Autonomic Nervous System; Spinal Cord Injury; Prevention

Outcome Measures

Primary Outcomes (1)

• 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): 1. Low risk - SBP to 150 mmHg 2. Moderate risk - SBP 150-200 mmHg 3. High risk - SBP above 200 mmHg

  During the intervention

Secondary Outcomes (3)

• Dermal sweating

  During the intervention

• Assessment of symptoms

  During the intervention

• ADFSCI questionnaire

  During the intervention

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Diagnostic Test: Clinical Examination

Interventions

Clinical Examination 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.

Also known as: 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

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• People with acute infection or other suddenly incurred complication

Sponsors & Collaborators

• Assoc. Prof. Jiri Kriz, MD, PhD: lead

Study Sites (1)

Department of Rehabilitation and Sports Medicine, University Hospital Motol

Prague, 150 06, Czechia

RECRUITING

Related Publications (3)

• 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.

  PMID: 26707873 BACKGROUND

• 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.

  PMID: 24621047 BACKGROUND

• 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.

  PMID: 24343054 BACKGROUND

MeSH Terms

Conditions

Autonomic Dysreflexia; Spinal Cord Injuries

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Central Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jiri Kriz, MD, PhD

  Spinal Cord Unit, University Hospital Motol

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiri Kriz, MD, PhD

CONTACT

+420224439207; jiri.kriz@fnmotol.cz

Renata Hakova, MD

CONTACT

+420224439265; renata.hakova@fnmotol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 27, 2021
• Study Start: January 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)