Autonomic Function Testing for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By PI

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Blood thinners

Disqualifiers: Cardiovascular disease, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

69 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the autonomic nervous system, which controls functions like blood pressure and bladder health, works after a spinal cord injury. Researchers will conduct tests, including autonomic dysreflexia testing, to assess the body's response to signals regulating these functions. Participants will wear a smartwatch to track key health indicators such as heart rate and skin temperature. The trial seeks individuals with traumatic spinal cord injuries who face challenges like blood pressure issues and bladder problems. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the understanding and treatment of spinal cord injuries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking blood thinners.

What prior data suggests that these autonomic function tests are safe?

Research has shown that ensuring the safety of treatments for conditions like autonomic dysreflexia, and understanding the body's response to stress and relaxation, is crucial for individuals with spinal cord injuries. For autonomic dysreflexia, studies have found that systems can accurately detect symptoms, aiding in the management of this condition. This is important because autonomic dysreflexia can be serious, but identifying and managing symptoms can reduce risks.

Tests examining the body's response to stress and relaxation are also under study. These tests enhance understanding of how the body balances signals that activate or calm it after a spinal cord injury.

Although the studies do not provide specific details about side effects, the emphasis on monitoring and managing body functions suggests that safety is closely monitored. This research aims to improve understanding and management of these conditions, which is vital for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to explore the autonomic function in individuals with spinal cord injury, which is a new approach compared to current treatments that primarily focus on motor and sensory recovery. This trial is unique because it investigates autonomic dysreflexia and tests both sympathetic activation and inhibition, which could lead to better management of autonomic dysfunction in these patients. By understanding these autonomic processes, researchers hope to develop interventions that could improve quality of life for those affected by spinal cord injuries.

What evidence suggests that these tests are effective for assessing autonomic dysfunction in spinal cord injury?

Research has shown that autonomic dysreflexia (AD) is a common and serious issue for people with spinal cord injuries, particularly those with injuries above the T6 level. AD causes dangerous increases in blood pressure due to disrupted automatic signals in the body. This trial includes separate arms for individuals with and without spinal cord injuries to assess autonomic function. Studies have found that testing and monitoring how the body controls blood pressure can help doctors manage these risks more effectively. Tests reveal how well the body controls blood flow and organ function, which often become disrupted after a spinal cord injury. Additionally, tests help understand how the body calms these responses, crucial for overall balance. These tests aim to provide a clearer picture of the autonomic nervous system's health, potentially leading to better treatment and management options for people with spinal cord injuries. ^{3 4 6 7 8}

Who Is on the Research Team?

Ryan Solinsky, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 with adult onset, traumatic spinal cord injury that occurred 1-5 years ago. They should have a range of autonomic dysfunction (American Spinal Injury Association Impairment Scale A-D) and injuries at the C1-T12 level. Exclusions include blood thinners use, incompatible implants with MRI, pregnancy, lactation, cognitive issues preventing consent, BMI >30 kg/m2 for controls only.

Inclusion Criteria

If you have a spinal cord injury, it must be classified as A-D on the American Spinal Injury Association Impairment Scale, which measures the severity of your injury.

If you have a spinal cord injury, it must be at a certain level defined by specific guidelines.

My spinal cord injury was caused by trauma as an adult.

Exclusion Criteria

I am not pregnant or breastfeeding.

I am able to understand and give consent for my participation.

I am currently on blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including the Autonomic Dysfunction Following Spinal Cord Injury questionnaire and the Composite Autonomic Symptom Score

1 week

1 visit (in-person)

Laboratory Diagnostic Testing

Participants undergo laboratory-based tests to assess autonomic nervous system function, including Valsalva maneuver, ECG, blood pressure monitoring, and smartwatch assessments

1 week

1 visit (in-person)

Follow-up

Participants are monitored for any changes in autonomic function and secondary complications

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Testing of autonomic dysreflexia
• Tests of sympathetic activation
• Tests of sympathetic inhibition

Trial Overview The study tests how well the autonomic nervous system functions after spinal cord injury by measuring blood pressure regulation and other responses. It includes lab tests to assess signal inhibition/activation in participants with injuries versus uninjured controls, smart watch monitoring at home for heart rate and skin temperature data, and MRI scans to analyze spinal cord connectivity patterns.

How Is the Trial Designed?

Group I: Individuals without spinal cord injury Experimental Treatment 3 Interventions

Group II: Individuals with spinal cord injury Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Published Research Related to This Trial

In a study involving rats with spinal cord injury (SCI), blood flow in the femoral arteries was significantly reduced, indicating impaired vasomotor function after injury.

The research found that the expression of α1-adrenergic receptors was increased in the arterial smooth muscle of rats with SCI, which enhances their responsiveness to certain stimuli and contributes to the development of autonomic dysreflexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord injury enhances arterial expression and reactivity of α1-adrenergic receptors-mechanistic investigation into autonomic dysreflexia. Lee, JS., Fang, SY., Roan, JN., et al.[2018]

The American Spinal Injury Association and the International Spinal Cord Society are developing new assessment criteria for evaluating autonomic function in individuals with spinal cord injury, aiming to enhance the understanding of neurological function and treatment effects.

The committee recommends assessing specific conditions related to autonomic dysfunction, including neurogenic shock, cardiac dysrhythmias, orthostatic hypotension, autonomic dysreflexia, temperature dysregulation, and hyperhidrosis, to improve clinical evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of autonomic dysfunction following spinal cord injury: rationale for additions to International Standards for Neurological Assessment. Krassioukov, AV., Karlsson, AK., Wecht, JM., et al.[2022]

A study involving 120 physiotherapists (52 undergraduates and 68 postgraduates) revealed that knowledge about autonomic dysreflexia (AD) was generally low, with 96.2% of undergraduates and 86.8% of postgraduates rating their knowledge as poor or nonexistent.

Higher knowledge scores were linked to having a master's degree, more than 5 years of practice, and more frequent interactions with patients who have spinal cord injuries, indicating a need for improved education on AD in physiotherapy training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do physiotherapists and physiotherapy students know about autonomic dysreflexia? Tederko, P., Ugniewski, K., Bobecka-Wesołowska, K., et al.[2021]

In a study of 48 spinal cord injury patients, those with injuries above the T6 level frequently experienced significant increases in blood pressure during urodynamic evaluations, indicating a risk for autonomic dysreflexia (AD).

The onset of AD was linked to bladder conditions such as uninhibited contractions and bladder distension, suggesting that while anticholinergic drugs may help, they are not always effective in preventing AD unless they cause detrusor areflexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autonomic dysreflexia during urodynamics. Giannantoni, A., Di Stasi, SM., Scivoletto, G., et al.[2019]

In a study of 78 male patients with spinal cord injury experiencing autonomic dysreflexia (AD), it was found that AD episodes were predominantly associated with relative tachycardia (68.0%), indicating a common cardiovascular response during these episodes.

The use of nitroglycerin ointment for bladder-related AD episodes resulted in a quicker reduction in blood pressure compared to non-bladder related episodes, suggesting it may be an effective treatment option for managing AD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring detailed characteristics of autonomic dysreflexia. Solinsky, R., Kirshblum, SC., Burns, SP.[2023]

A 73-year-old male with cervical stenosis experienced autonomic dysreflexia (AD) symptoms, including hot flashes and palpitations, which were resolved after undergoing anterior cervical decompression and fusion surgery.

This case suggests that autonomic dysreflexia can occur due to cervical spinal stenosis, highlighting the need for clinicians to consider this association beyond typical spinal cord injury cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autonomic dysreflexia caused by cervical stenosis. Khanna, K., Theologis, AA., Tay, B.[2022]

In a study of 10 subjects with complete spinal cord injury above T6, silent autonomic dysreflexia was frequently observed during routine bowel programs, with significant increases in systolic blood pressure (SBP) noted.

Despite no subjects reporting classic symptoms of autonomic dysreflexia, 60% experienced SBP increases above 150 mmHg, indicating a need for further research on potential preventative measures or treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Silent autonomic dysreflexia during a routine bowel program in persons with traumatic spinal cord injury: a preliminary study. Kirshblum, SC., House, JG., O'connor, KC.[2022]

Sympathetic skin responses (SSRs) are a quick and non-invasive way to assess autonomic dysfunction in patients with spinal cord injury (SCI), showing that autonomic impairment can occur independently of sensorimotor issues.

The review emphasizes the importance of using SSRs alongside other validated tests to better predict and document autonomic dysfunction, particularly conditions like autonomic dysreflexia and orthostatic hypotension in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sympathetic skin responses and autonomic dysfunction in spinal cord injury. Berger, MJ., Hubli, M., Krassioukov, AV.[2014]

A study involving 100 individuals with chronic spinal cord injury (SCI) and 16 family members revealed significant gaps in knowledge about autonomic dysreflexia (AD), with 41% of participants unaware of the condition and 22% experiencing unrecognized symptoms.

Education on AD recognition and management is best delivered during rehabilitation by healthcare professionals, which could help reduce the risk of serious complications like cardiac and cerebrovascular disease in the SCI population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating knowledge of autonomic dysreflexia among individuals with spinal cord injury and their families. McGillivray, CF., Hitzig, SL., Craven, BC., et al.[2021]

In a study of 13 pediatric patients with spinal cord injury (SCI) at or above T8 and other severe neurological disorders undergoing urodynamic studies (UDS), only two patients developed autonomic dysreflexia (AD), indicating a low prevalence in this specific population.

AD was effectively managed conservatively without major complications, and the study found that patients who experienced AD during their first UDS were at increased risk for subsequent episodes, while those who did not experience AD initially did not develop it in later tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autonomic dysreflexia during urodynamics in children and adolescents with spinal cord injury or severe neurologic disease. Canon, S., Shera, A., Phan, NM., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8152175/

Evaluation and Management of Autonomic Dysreflexia and ... Autonomic dysreflexia (AD) and other autonomic dysfunctions are commonly seen after spinal cord injury (SCI). However, since SCI is relatively uncommon and the ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2025.2485509

Evaluation and management of autonomic functions in ... This review outlines available clinical data on measuring and managing CV autonomic dysfunction after SCI and identifies gaps in these domains.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772973723000231

Autonomic Dysreflexia (AD): A serious, rather ... Autonomic Dysreflexia (AD) is a common complication among patients with a Spinal Cord Lesion (SCL) located above the T6 level.

4. emedicine.medscape.com emedicine.medscape.com/article/322809-overview

Autonomic Dysreflexia in Spinal Cord Injury Autonomic dysreflexia is a potentially dangerous and, in rare cases, lethal clinical syndrome that develops in individuals with spinal cord injury (SCI).

5. nature.com nature.com/articles/s41598-024-53718-5

Advancing spinal cord injury care through non-invasive ... This paper presents an AI-powered solution for detecting and monitoring Autonomic Dysreflexia (AD) in individuals with spinal cord injuries.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7028437/

Automated Detection of Symptomatic Autonomic ... Results: The PTS could detect onset of AD symptoms with an average accuracy of 94.10% and a false negative rate of 4.89%. Conclusions: The PTS can detect the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772973725008975

Autonomic dysreflexia during urodynamics: A systematic ... This systematic review identified the incidence of AD during urodynamics in SCI to be high, although results regarding predictors of AD were variable.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05024487?cond=%22Autonomic%20Dysreflexia%22&viewType=Table&rank=8

Prevention of Complications Due to Autonomic Dysreflexia ... The ADFSCI (Autonomic Dysfunction Following Spinal Cord Injury) questionnaire provides information about individual symptoms of blood pressure (BP) instability.