Prevention of Complications Due to Autonomic Dysreflexia in SCI Individuals

March 12, 2023 updated by: Assoc. Prof. Jiri Kriz, MD, PhD

Risk Level Determination of Vascular Complications Due to Autonomic Dysreflexia in Spinal Cord Injured Individuals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 150 06
        • Recruiting
        • Department of Rehabilitation and Sports Medicine, University Hospital Motol
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Diagnostic test: 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.
Other 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood pressure monitoring
Time Frame: During the intervention

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dermal sweating
Time Frame: During the intervention

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.
During the intervention
Assessment of symptoms
Time Frame: During the intervention

Subjective individual symptoms are divided into three groups, according to their severity (minimum value: mild symptoms, maximum: strong symptoms):

  1. Mild symptoms - shivers on the nape or on the back
  2. Moderate symptoms - sweating on the forehead, neck or upper extremities
  3. Strong symptoms - pounding headache, nausea
During the intervention
ADFSCI questionnaire
Time Frame: During the intervention
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.
During the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assoc. Prof. Jiri Kriz, MD, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCI_DYSREFLEXIA_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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