Autonomic Characterization for Spinal Cord Injury

Overseen By Zachary Pohlkamp

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Phenylephrine interactions

Disqualifiers: Cardiovascular, Respiratory, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body manages blood pressure changes after a spinal cord injury and how these changes affect future health risks. Researchers aim to understand this by observing individuals over time through Longitudinal Autonomic Characterization. Participants with spinal cord injuries, specifically between the neck and mid-back (C6-T12), may qualify if their injury occurred either less than three months ago or more than a year ago. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance future health outcomes for individuals with spinal cord injuries.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that might interact badly with phenylephrine. It's best to discuss your current medications with the trial team.

What prior data suggests that this protocol is safe for spinal cord injury patients?

Research has shown that Longitudinal Autonomic Characterization involves observing how the body manages blood pressure changes over time, particularly after a spinal cord injury. Other studies have used this method to understand early physical and psychological changes. It focuses on observing the body's reactions rather than testing a new drug or surgery.

No specific reports of side effects have emerged from this type of observation, suggesting it is generally safe. This safety is due to its focus on monitoring existing conditions rather than altering them. As a "Not Applicable" phase study, it does not test a direct treatment. Instead, the study is observational, aiming to monitor and understand natural changes in the body after an injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the longitudinal autonomic characterization for spinal cord injury because it aims to provide a deeper understanding of how spinal cord injuries affect the autonomic nervous system over time. Unlike current treatments that primarily focus on physical rehabilitation or symptom management, this approach seeks to map out changes and responses in the autonomic functions, which could lead to more personalized and effective interventions. By studying both acute and chronic spinal cord injuries, this method could uncover crucial insights that help optimize existing therapies and potentially guide the development of new treatments.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that tracking changes in blood pressure over time can be very helpful. This method, known as Longitudinal Autonomic Characterization, is particularly important for individuals with spinal cord injuries. In this trial, participants with either chronic or acute spinal cord injury will undergo this characterization to monitor physical and mental changes as they occur. Studies have found that checking blood pressure variability is an easy and useful way to understand how the body's involuntary nervous system functions, particularly a month after an injury. This can help predict other health issues and possibly improve recovery. In short, closely watching how the body reacts and adapts could lead to better health management for those with spinal cord injuries. ^{1 2 3 4 5}

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 individuals aged 18-75 with a spinal cord injury (SCI) at levels C6-T12. It includes those with recent SCI (<3 months ago) and chronic SCI (>1 year since injury). Pregnant or lactating women, people on certain medications, or those with conditions that could affect the study are excluded.

Inclusion Criteria

ASIA Impairment Scale A-D

I am between 18 and 75 years old.

My spinal cord injury happened either less than 3 months ago or more than 1 year ago.

Exclusion Criteria

I am not pregnant or breastfeeding.

In the judgement of the principal investigator, any illness or condition that will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

I am taking medication that may not mix well with phenylephrine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laboratory Diagnostic Testing

Participants undergo various diagnostic tests including Valsalva maneuver, ECG, and blood pressure monitoring

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Longitudinal Autonomic Characterization

Trial Overview

The study tests how well participants' bodies manage blood pressure changes after an SCI. It involves monitoring autonomic responses to assess risk of secondary medical complications over time through various sympathetic activation and inhibition tests.

How Is the Trial Designed?

Group I: Chronic Spinal Cord Injury Experimental Treatment 3 Interventions

Group II: Acute Spinal Cord Injury Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07210437?term=NA

Longitudinal Autonomic Characterization as a Predictor for ...

The purpose of this research is to learn about how the body is able to balance changes in blood pressure, how that changes over time, and how these changes ...

2.

trialx.com

trialx.com/clinical-trials/listings/308163/longitudinal-autonomic-characterization-as-a-predictor-for-secondary-medical-complications-post-sci/

Longitudinal Autonomic Characterization as a Predictor for ...

The purpose of this research is to learn about how your body is able to balance changes in blood pressure, how that changes over time, and how these changes ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/10569437/

Longitudinal outcomes in spinal cord injury

The longitudinal method, like cross-sectional research, allows for identification of physical and psychosocial changes soon after they occur.

4.

journals.sagepub.com

journals.sagepub.com/doi/full/10.1089/neu.2020.7286

Use of Low-Frequency Blood Pressure Variability as a ...

LF SAP provides a simple, non-invasive, translatable, quantitative assessment of autonomic function, and is most informative 1 month after injury. Introduction.

5.

nature.com

nature.com/articles/s41598-024-71983-2

Long-term outcome and predictors of neurological recovery ...

This retrospective study analyzed prognostic factors for neurological improvement and ambulation in 194 adult patients (≥ 15 years) with traumatic cervical ...