Clinical Trials Logo

Clinical Trial Summary

Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.


Clinical Trial Description

Based on available evidence, TSCS may have advantages over current pharmacological approaches to the treatment of hypotension and OH: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. TSCS represents an alternate approach to epidural SCS, with far greater potential to reach large numbers of individuals, thus providing for a greater likelihood of clinical implementation with fewer risk. We are asking several key questions: (1) what are the effects of TSCS on seated BP and BP changes during an orthostatic challenge, (2) is the application of TSCS during AIR tolerable based on pain reporting, (3) is there evidence of superficial burns to the skin near the site of cathode or anode placement, and (4) are the symptoms of orthostatic intolerance reduced with TSCS? To facilitate adoption of TSCS for widespread clinical use, we have designed a spatial-temporal mapping and parameter configuration approach that will result in a key deliverable for SCI care: a standard, easy to follow algorithm that will maximize individual benefits of spinal neuromodulation, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS for widespread clinical utility in the newly injured SCI population, thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by autonomic nervous system dysfunction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06000592
Study type Interventional
Source James J. Peters Veterans Affairs Medical Center
Contact Jorge Chavez, BS
Phone (914)343-0713
Email jorge.chavez2@mountsinai.org
Status Recruiting
Phase N/A
Start date January 1, 2022
Completion date October 1, 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06321172 - Muscle and Bone Changes After 6 Months of FES Cycling N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05484557 - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Not yet recruiting NCT05506657 - Early Intervention to Promote Return to Work for People With Spinal Cord Injury N/A
Recruiting NCT04105114 - Transformation of Paralysis to Stepping Early Phase 1
Recruiting NCT03680872 - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System N/A
Completed NCT04221373 - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Completed NCT03898700 - Coaching for Caregivers of Children With Spinal Cord Injury N/A
Recruiting NCT04883463 - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury N/A
Active, not recruiting NCT04881565 - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES) N/A
Completed NCT04864262 - Photovoice for Spinal Cord Injury to Prevent Falls N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Active, not recruiting NCT04544761 - Resilience in Persons Following Spinal Cord Injury
Terminated NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Recruiting NCT04811235 - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial N/A
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A