NCT06313515

Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI

Recruiting now NA Last updated 19 September 2024

What this trial tests

NA trial testing Transcutaneous Spinal Cord Stimulation in Spinal Cord Injuries in 16 participants. Currently enrolling.

Timeline

1 April 2024

Primary endpoint
1 February 2026

1 February 2027

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	16
Start date	1 April 2024
Primary completion	1 February 2026
Estimated completion	1 February 2027
Sites	1 location across United States

Drugs / interventions tested

• Transcutaneous Spinal Cord Stimulation
• Arm-crank bike exercise
• Sham Stimulation

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

University of Washington

Who can join

Adults 21 to 65, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6).

The main questions the study aims to answer are:

* Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6.
* Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6.
* Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6.
* Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise.

Participants will:

* Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks.
* Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise.
* During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning.

Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710
2. Strategies to Augment the Cardiovascular System and Acutely Enhance Exercise Performance in Individuals with Spinal Cord Injury: A Systematic Scoping Review.
   Hodgkiss DD, Balthazaar SJT, Gee CM, Chiou SY, et al · · 2025 · PMID 41196455 · DOI 10.1186/s40798-025-00909-7
3. Electroceuticals for Paralympic Athletes: A Fair Play and Classification Concern?
   Hodgkiss DD, Balthazaar SJT, Gee CM, Boardley ID, et al · · 2026 · PMID 41082173 · DOI 10.1007/s40279-025-02331-1