Device-Assisted Exercise for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen by Jill M Wecht, EdD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Seizures, Ventilator dependence, Cardiovascular, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your medication regimen has been stable for at least 30 days before joining.

What data supports the effectiveness of the treatment DS8R Biphasic Constant Current Stimulator for spinal cord injury?

Research on similar treatments, like functional electrical stimulation (FES), shows that electrical stimulation can improve muscle strength, walking speed, and bone health in people with spinal cord injuries. For example, one study found that FES increased walking speed by nearly 50% over a year, and another reported significant improvements in walking distance and speed after 12 weeks of training with an implanted FES system. ^{1 2 3 4 5}

Is device-assisted exercise using functional electrical stimulation safe for people with spinal cord injuries?

Research shows that functional electrical stimulation (FES) is generally safe for people with spinal cord injuries, as studies have reported no major safety concerns during various exercise programs using FES. ^{3 6 7 8 9}

How is the DS8R treatment different from other treatments for spinal cord injury?

The DS8R treatment is unique because it uses a biphasic constant current stimulator to assist exercise, which may enhance muscle activation and improve mobility in spinal cord injury patients. This approach is different from other treatments that often rely on functional electrical stimulation (FES) systems, which are typically used for gait training and require implanted or external devices to stimulate specific muscles. ^{2 3 4 5 10}

Research Team

Jill M Wecht, EdD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

This trial is for individuals with a spinal cord injury at levels C3-T1, classified as AIS A or B, who are non-ambulatory and have had their injury for over a year. Participants must be on stable medications for 30 days and commit to 7 visits in 60 days. It's not suitable for those with recent seizures, psychological disorders, substance abuse, open skin lesions on the spine, ventilator dependence, other neurological disorders or head trauma.

Inclusion Criteria

I had an injury over a year ago and cannot walk.

My spinal cord injury is between C3 and T1 and is classified as severe.

Must be able to commit to study requirements of 7 visits within a 60-day period

Exclusion Criteria

I have had a serious head injury in the past.

I have a serious heart condition.

I rely on a ventilator to breathe or have an open tracheostomy.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline Assessment

Determining baseline autonomic function and screening for hypotension and orthostatic hypotension

1 visit

1 visit (in-person)

Stimulation Parameter Determination

Determine optimal stimulation site on the spine (T7-T8 or T11-12) to increase seated systolic blood pressure

2 visits

2 visits (in-person)

Treatment

Participants undergo submaximal arm ergometry exercise with optimal electrode placement and a sham visit

2 visits

2 visits (in-person)

Temperature Regulation Assessment

Assess core temperature in a cool environment with stimulator on and off

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

Treatment Details

Interventions

• DS8R (Spinal Cord Stimulation)

Trial Overview The study tests if transcutaneous spinal cord stimulation can improve blood pressure control and exercise endurance during arm cycling exercises. It also examines whether this stimulation aids body temperature regulation in cool environments.

Participant Groups

Group I: With stimulation Active Control 3 Interventions

For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry with stimulation. For study 2, body core temperature and thermal comfort will be reported with stimulation.

Group II: Without stimulation Placebo Group 2 Interventions

For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry without stimulation. For study 2, body core temperature and thermal comfort will be reported without stimulation.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

Intermittent electrical stimulation for 1-2 hours daily can significantly enhance muscle strength and endurance, and even reverse some osteoporosis in bones affected by spinal cord injury.

In a multicenter study, participants experienced nearly a 20% increase in walking speed initially, with sustained improvements of almost 50% after a year of continued stimulation, indicating both immediate and long-term benefits of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation after spinal cord injury. Stein, RB.[2006]

In a pilot study involving 11 participants with incomplete spinal cord injuries, the iCycle device, which combines Functional Electrical Stimulation (FES) with voluntary effort through virtual reality biofeedback, showed significant improvements in motor scores for some participants, particularly those with sub-acute injuries.

The study found that 4 out of 5 sub-acute participants and 2 out of 6 chronic participants improved their motor scores by more than 8 points, suggesting that the iCycle may enhance neurological recovery, although further controlled trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study. Duffell, LD., Paddison, S., Alahmary, AF., et al.[2020]

In a study involving 12 individuals with complete spinal cord injury, FES-assisted dynamic load-shifting exercises led to significant increases in trabecular bone mineral density (vBMD) in the proximal and distal tibia after 29 weeks of training, indicating potential benefits for bone health in this population.

While improvements were noted in the tibia, there was no increase in vBMD in the distal femur, suggesting that the effectiveness of FES exercises may vary by bone location and type of exercise performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Functional Electrical Stimulation-assisted posture-shifting in bone mineral density: case series-pilot study. Armengol, M., Zoulias, ID., Gibbons, RS., et al.[2022]

The Parastep method, a functional electrical stimulation device, enabled 13 out of 15 spinal cord-injured patients to achieve independent ambulation with a walker after an average of 20 training sessions, demonstrating its potential for improving mobility.

Despite its benefits, the Parastep method has limited applications for daily mobility due to high energy costs and cardiovascular strain, although it can still provide significant psychological and physical fitness benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with functional electrical stimulation-assisted gait with Parastep in spinal cord-injured patients. Brissot, R., Gallien, P., Le Bot, MP., et al.[2019]

An implanted functional electrical stimulation (FES) system significantly improved walking capabilities in an individual with incomplete cervical spinal cord injury, increasing walking distance from 14 meters to 309 meters and walking speed from 0.02 m/s to 0.20 m/s over 12 weeks of training.

The system was well-tolerated and reliable, demonstrating a fivefold reduction in physiological cost index, indicating that the participant could walk with less effort, although voluntary locomotor function remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking after incomplete spinal cord injury using an implanted FES system: a case report. Hardin, E., Kobetic, R., Murray, L., et al.[2019]

The study involving 19 spinal cord injured individuals demonstrated that computerized functional electrical stimulation (FES) is safe and effective in increasing quadriceps strength and endurance after a training program.

Participants showed improved endurance on a lower extremity ergometer, indicating a potential training effect, as they were able to perform more work at similar heart rates and blood pressure levels, although further research is needed to fully understand the cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of computerized functional electrical stimulation after spinal cord injury: a multicenter pilot study. Ragnarsson, KT., Pollack, S., O'Daniel, W., et al.[2004]

Hybrid High-Intensity Interval Training (HIIT) using Functional Electrical Stimulation (FES) was found to be safe and well-accepted by participants with spinal cord injuries, with no serious adverse events reported during the 8-week study involving 8 participants.

Participants experienced a significant 17% increase in peak oxygen uptake (VO2peak) and reported improvements in leisure time physical activity and quality of life, indicating that this training method can enhance physical fitness and overall well-being for individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. Vestergaard, M., Jensen, K., Juul-Kristensen, B.[2022]

A 12-week progressive functional electric stimulation (FES) rowing training program significantly improved peak functional aerobic power in individuals with spinal cord injury, with peak oxygen consumption increasing by 11.2% and rowing distance by 25%.

The ROWSTIM II device was found to be safe and well-accepted by participants, demonstrating that FES-assisted rowing is an effective training method for enhancing aerobic capacity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. Wheeler, GD., Andrews, B., Lederer, R., et al.[2019]

In a study involving 15 patients with chronic spinal cord injury, functional electrical stimulation (FES) cycling for 6 weeks significantly improved functional independence and mobility, as indicated by better scores on the Functional Independence Measure (FIM) and improved performance in walking tests.

FES cycling also led to a notable increase in forced vital capacity (FVC), suggesting benefits for pulmonary function, while biochemical values did not show significant changes, indicating that FES cycling is a safe and effective rehabilitation intervention for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation cycling in patients with chronic spinal cord injury: a pilot study. Gurcay, E., Karaahmet, OZ., Cankurtaran, D., et al.[2022]

A new system using commercially available electrical muscle stimulators successfully enabled a C7-level quadriplegic individual to perform functional ambulation exercises, including over 20 repetitions of stand-up and sit-down activities and walking distances of about 0.8 km at speeds of 1.2 to 2.0 km/h.

Muscle fatigue was identified as the main limiting factor for the patient, suggesting that a physical conditioning program should precede the use of this system for walking exercises, and specific medical criteria must be met before prescribing it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation and lower extremity bracing for ambulation exercise of the spinal cord injured individual: a medically prescribed system. Phillips, CA.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation after spinal cord injury. [2006]

2. England pubmed.ncbi.nlm.nih.gov

The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

The effect of Functional Electrical Stimulation-assisted posture-shifting in bone mineral density: case series-pilot study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical experience with functional electrical stimulation-assisted gait with Parastep in spinal cord-injured patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Walking after incomplete spinal cord injury using an implanted FES system: a case report. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of computerized functional electrical stimulation after spinal cord injury: a multicenter pilot study. [2004]

7. England pubmed.ncbi.nlm.nih.gov

Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation cycling in patients with chronic spinal cord injury: a pilot study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation and lower extremity bracing for ambulation exercise of the spinal cord injured individual: a medically prescribed system. [2019]