Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries

• Registration Number: NCT07210411
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to learn about how your body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in patients with spinal cord injury.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Study Start: 2025-11-01
• Primary Completion: 2030-12-31
• Study Completion: 2031-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Valsalva Maneuver Phase II	During laboratory diagnostic testing session	Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.

Secondary Outcome Measures

Name	Time	Method
Beat-to-beat heart rate	During laboratory diagnostic testing session	Electrocardiogram will record continuous measures with changes in R-R interval (ms) quantified and compared to baseline.
Beat-to-beat blood pressure	During laboratory diagnostic testing session	Non-invasive continuous blood pressure monitors will be used, with changes in systolic and diastolic pressure (in mmHg) from resting baseline measured.
Continuous galvanic skin response	During laboratory diagnostic testing session	Changes from resting state conductance with be quantified with a smartwatch.
Quantify autonomic dysreflexia and orthostatic hypotension	Baseline, prior to laboratory diagnostic testing session	Participants will be given the Autonomic Dysfunction Following Spinal Cord Injury questionnaire (score range 0-436, with higher scores indicating more autonomic dysfunction).
Respiration	During laboratory diagnostic testing session	Elastic respiratory transducer bands around mid-chest and upper abdomen will monitor breathing depth and frequency.
Beat-by-Beat Popliteal and Brachial Blood Flow	During laboratory diagnostic testing session	We will use Doppler derived flow velocities to estimate whole limb blood flow through the popliteal and brachial arteries
Immunology Blood Draw	During laboratory diagnostic testing session	Baseline samples will be collected and compared against changes to blood pressure.
Serum Catecholamines and Cortisol	During laboratory diagnostic testing session	Baseline resting catecholamines (norepinephrine, epinephrine, dopamine) and cortisol will be drawn from the IV after 10 minutes of quiet rest at baseline and prior to bladder filling or foot cold pressor. Just prior to the conclusion of this testing, an additional blood draw will take place through the IV to assess changes in these levels.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States