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

NCT06313515 | Recruiting DMC

• 1 other identifier: STUDY00019529
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. Assessment procedures also include stool sample and nasal swab collection. 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.

Conditions

Spinal Cord Injuries

Keywords

Transcutaneous Spinal Cord Stimulation; Arm-Bike Exercise; Cardiovascular Function

Outcome Measures

Primary Outcomes (3)

• Change in systolic Blood Pressure (BP) from baseline.

  Continuous beat-by-beat BP will be measured using a finger photoplethysmography.

  Baseline

• Change in systolic Blood Pressure during a sit-up test or head-up tilt test.

  Continuous beat-by-beat BP will be measured during a orthostatic challenge.

  Repeated measurements before and after each 8 week-intervention block, an average of 6 months

• Heart rate variability recorded by electrocardiogram (ECG).

  Parameters using RR intervals (R-wave peak to R-wave peak in electrocardiogram) processed to assess the activity of autonomic nervous system.

  Repeated measurements before and after each 8 week-intervention block, an average of 6 months

Secondary Outcomes (10)

• Peak oxygen uptake (VO2peak)

  Repeated measurements before and after each 8 week-intervention block, an average of 6 months

• Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure

  Repeated measurements before and after each 8 week-intervention block, an average of 6 months

• International Standards for Neurological Classification of Spinal Cord Injury

  Repeated measurements before and after each 8 week-intervention block, an average of 6 months

• International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)

  Repeated measurements before and after each 8 week-intervention block, an average of 6 months

• Blood Pressure variability

  Repeated measurements before and after each 8 week-intervention block, an average of 6 months

Study Arms (2)

tSCS paired with arm-crank exercise

EXPERIMENTAL

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.

Device: Transcutaneous Spinal Cord Stimulation; Behavioral: Arm-crank bike exercise

Sham stimulation paired with arm-crank exercise

SHAM COMPARATOR

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.

Device: Transcutaneous Spinal Cord Stimulation; Behavioral: Arm-crank bike exercise; Other: Sham Stimulation

Interventions

Transcutaneous Spinal Cord Stimulation DEVICE

Non-invasive electrical stimulation of the spinal cord over the skin

Also known as: tSCS

Sham stimulation paired with arm-crank exercise; tSCS paired with arm-crank exercise

Arm-crank bike exercise BEHAVIORAL

Exercise using an arm-bike to target cardiovascular functioning.

Also known as: arm-crank exercise

Sham stimulation paired with arm-crank exercise; tSCS paired with arm-crank exercise

Sham Stimulation OTHER

Non-invasive electrical stimulation of a lower extremity muscle group over the skin.

Sham stimulation paired with arm-crank exercise

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are between 21-65 years of age.
• Chronic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal cord segment.
• Greater than ten months post injury or diagnosis, at least 6 months from any spinal surgery.
• American Spinal Injury Association Impairment Scale (AIS) A, B for SCI.
• Have stable medical condition without cardiopulmonary disease that would contraindicate participation in intensive training or testing activities.
• Cleared for strenuous exercise with arm bike by a primary physician of the subject (the clearance for intensive training with arm bike is obtained verbally or through a written form by a primary physician.)
• Willing and able to comply with all clinic visits and study-related procedures.
• Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
• Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
• Are with stable management of spinal cord related clinical issues (i.e., spasticity management).
• Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
• Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
• Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
• Are volunteering to be involved in this study.
• Has adequate social support to be able to participate in training and assessment sessions, up to 3 sessions per week, for the duration of up to 6 months within the study period.

You may not qualify if:

• Have autoimmune etiology of spinal cord dysfunction/injury
• Have history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.
• Have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
• Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
• Are ventilator dependent.
• Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
• Use any medication or treatment that in the opinion of the investigators indicates that it is not in the best interest of the participant to participate in this study.
• Have Intrathecal baclofen pump.
• Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
• Have severe acute medical issue that in the investigators' judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications \[tricyclics\], debilitating muscle pain, pressure sores, or unstable diabetes.
• Have pacemakers, stimulators, medication pumps in the trunk, deep brain stimulators, metallic devices in the head such as aneurysm clips/coils and stents, vagus nerve stimulators.
• Take more than 40 mg of Baclofen per day
• Have severe anemia (Hgb\<8 g/dl or Hgb,80 g/L) or hypovolemia as measured by hematocrit via blood test in the last six months.
• Are a member of the investigational team or his/her immediate family.
• Have undergone electrode implantation surgery.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Soshi Samejima, DPT, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soshi Samejima, DPT, PhD

CONTACT

2066160462; soshis@uw.edu

Katie Singsank

CONTACT

2065430110; singsank@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine

Model Details: randomized, single-blind, sham-controlled trial with two arms (tSCS paired with arm-crank exercise compared to sham stimulation with exercise). Participants will be randomized into either the intervention or sham stimulation arm. Those in the sham arm only will initially receive sham stimulation, but then cross over to receive the active treatment arm, such that by the end all participants will have been exposed to the tSCS. tSCS participants will not receive sham stimulation.

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 15, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)