Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Spinal Cord Injuries

Clinical Trial Details

NCT number	NCT06313515
Study type	Interventional
Source	University of Washington
Contact	Soshi Samejima, DPT, PhD
Phone	2066160462
Email	soshis@uw.edu
Status	Recruiting
Phase	N/A
Start date	April 1, 2024
Completion date	February 1, 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms