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Behavioral Intervention

tSCS paired with arm-crank exercise for Spinal Cord Injury

N/A
Recruiting
Led By Soshi Samejima, DPT, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up repeated measurements before and after each 8 week-intervention block, an average of 6 months
Awards & highlights

Study Summary

This trial aims to test a combination therapy of moderate arm-crank exercise with spinal cord stimulation in adults with chronic spinal cord injury to improve cardiovascular function. Participants will undergo stimulation while exercising on an arm-c

Who is the study for?
Adults aged 21-65 with chronic motor-complete spinal cord injury at or above T6, who are medically stable and cleared for arm bike exercise. Participants must understand English (or have an interpreter), be free of certain health issues like unhealed fractures or infections, and not have cardiopulmonary diseases that would make intense training unsafe.Check my eligibility
What is being tested?
The trial is testing if transcutaneous spinal cord stimulation (tSCS) combined with moderate arm-crank exercise improves cardiovascular function in those with SCI compared to sham stimulation plus exercise. It involves up to 60 visits over six months for exercises and assessments.See study design
What are the potential side effects?
Potential side effects may include discomfort from the stimulation, muscle fatigue from the arm-crank exercise, skin irritation where electrodes are placed, but specific side effects will depend on individual responses to tSCS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~repeated measurements before and after each 8 week-intervention block, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and repeated measurements before and after each 8 week-intervention block, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in systolic Blood Pressure (BP) from baseline.
Change in systolic Blood Pressure during a sit-up test or head-up tilt test.
Heart rate variability recorded by electrocardiogram (ECG).
Secondary outcome measures
Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure
Blood Pressure variability
Change from baseline- Capabilities of Upper Extremity Test
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: tSCS paired with arm-crank exerciseExperimental Treatment2 Interventions
Device: Transcutaneous Spinal Stimulation Non-invasive electrical stimulation of the spinal cord over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning.
Group II: Sham stimulation paired with arm-crank exercisePlacebo Group3 Interventions
Device: Sham Stimulation Non-invasive electrical stimulation of a lower extremity muscle group over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,750 Total Patients Enrolled
Soshi Samejima, DPT, PhDPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for participation in this trial, specifically regarding individuals above 55 years old?

"This research is seeking participants who are above 21 years old but below the age of 65."

Answered by AI

Are participants still being actively enrolled in this research study at the moment?

"Indeed, the details on clinicaltrials.gov reveal that this trial is currently open for participant recruitment. It was initially posted on April 1st, 2024 and last revised on March 16th, 2024. The study aims to enroll a total of 16 participants from one designated site."

Answered by AI

What is the current number of individuals being recruited for participation in this research endeavor?

"Affirmative. Information available on clinicaltrials.gov highlights that this research endeavor is presently seeking eligible participants. The trial was initially disclosed on April 1st, 2024, and the most recent revision occurred on March 16th, 2024. A total of 16 individuals are sought from a single designated location for enrollment in this study."

Answered by AI

What are the main goals being pursued in this medical study?

"The primary endpoint of this clinical investigation, to be assessed during a Baseline timeframe, is the alteration in systolic Blood Pressure observed during sit-up or head-up tilt trials. Secondary endpoints encompass gathering data on International [Spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) Lower Urinary Tract Function Dataset; an instrument utilized for evaluating lower urinary tract function among individuals with spinal cord injuries. Furthermore, assessments will include the application of International Standards for Neurological Classification of Spinal Cord Injury by skilled evaluators to ascertain motor and sensory pathway impairment levels. Finally, Autonomic Dysfunction following Spinal Cord Injury (ADFSCI) measure will gauge both severity and occurrence frequency of autonomic dys"

Answered by AI

What are the specific criteria for eligibility to participate in this medical study?

"The trial is seeking 16 candidates aged between 21 and 65 with spinal cord injury. Eligible participants must have controlled management of spinal-related clinical concerns like spasticity, possess English proficiency or access to a translator approved by the investigator for completing study assessments, receive approval from their primary physician for strenuous arm bike exercises, be rated as AIS A or B on the American Spinal Injury Association Impairment Scale (AIS), lack painful musculoskeletal issues, fractures in healing process, pressure sores, or active infections that might impede evaluations; exhibit chronic SCI without progression involving total motor paralysis at T6 level or higher"

Answered by AI
~11 spots leftby Feb 2026