Blood Flow Restricted Exercise + Transspinal Stimulation for Quadriplegia

(SCIMS Main Trial)

Recruiting at 3 trial locations

Overseen By Refka Khalil

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Unhealed fractures, Severe scoliosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants stop taking anti-coagulants or anti-platelet agents, including aspirin, unless they cannot be off these medications for medical reasons.

What data supports the effectiveness of the treatment Blood Flow Restricted Exercise + Transspinal Stimulation for Quadriplegia?

Blood flow restriction (BFR) training has been shown to improve muscle strength in various conditions, including incomplete spinal cord injury and multiple sclerosis, by using low-intensity exercises with restricted blood flow. This suggests potential benefits for muscle function in quadriplegia as well. ^{1 2 3 4 5}

Is Blood Flow Restriction Training safe for humans?

Blood Flow Restriction Training (BFR) has been shown to be safe in healthy older adults and the able-bodied population, but its safety in people with cardiovascular disease or musculoskeletal disorders is not well established. ^{1 3 6 7 8}

How is the treatment of Blood Flow Restricted Exercise and Transspinal Stimulation for quadriplegia different from other treatments?

This treatment is unique because it combines blood flow restriction (BFR) exercise, which uses a tourniquet to limit blood flow during exercise, with transspinal stimulation, which involves electrical stimulation of the spinal cord to improve blood flow and muscle function. This combination aims to enhance muscle strength and function in individuals with spinal cord injuries, offering a novel approach compared to traditional therapies. ^{1 2 4 9 10}

What is the purpose of this trial?

The purpose of the current study is to evaluate whether a home-based, telehealth-supported intervention combining Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) will improve motor and functional abilities greater than BES+sham TS in persons with chronic, incomplete tetraplegia.

Research Team

Ashraf Gorgey, MPT, PhD, FACSM, FACRM

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for individuals with chronic, incomplete tetraplegia who can safely engage in the study exercises and have a companion to assist them. They must be able to use telehealth technology, be over one year post spinal cord injury (SCI), and not have severe neurological conditions or implanted devices that could interfere with the interventions.

Inclusion Criteria

Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software

My wrist muscles respond to electrical stimulation therapy.

I have someone who can assist me during the study.

Exclusion Criteria

I do not have an implanted device, cancer, thrombosis, pacemaker, defibrillator, seizures, and I'm not on blood thinners.

I do not have severe scoliosis or arm contractures that would stop me from participating in specific physical activities.

I am experiencing symptoms of a urinary tract infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment and Training

Baseline assessments and training on the use of TS device and blood pressure machine, with massed practice training

4 weeks

2 visits/week (in-person and telehealth)

Treatment

Participants receive 16 weeks of BES+TS or BES+sham TS training at home with telehealth supervision

16 weeks

3 sessions/week (telehealth)

Post-Intervention Assessment

Post-intervention outcome measures assessments

1 week

1 visit (in-person)

Washout

Participants receive no training to observe any lasting effects of the intervention

8 weeks

Follow-up

Participants are monitored for long-term effects of the intervention

1 week

1 visit (in-person)

Treatment Details

Interventions

• Blood Flow Restricted Exercise
• Transspinal Stimulation

Trial Overview The study tests if combining Blood Flow Restricted Exercise (BES) with Transspinal Stimulation (TS) at home via telehealth improves motor functions more than BES combined with sham TS in people with incomplete tetraplegia.

Participant Groups

Group I: BES+sham TS Experimental Treatment 1 Intervention

Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) sham treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

Group II: BES+TS Experimental Treatment 1 Intervention

Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

Blood Flow Restricted Exercise is already approved in United States, European Union for the following indications:

Approved in United States as Blood Flow Restriction Training for:

• Orthopedic rehabilitation
• Muscle strengthening
• Pain relief
• Prevention of muscle atrophy

Approved in European Union as Blood Flow Restriction Training for:

• Rehabilitation after orthopedic surgery
• Muscle strengthening in patients with weight-bearing restrictions
• Pain management

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Administration for Community Living

Collaborator

Trials

1

Recruited

40+

ACL Administration for Community Living

Collaborator

Trials

2

Recruited

2,000+

Department of Health and Human Services Administration For Community Living

Collaborator

Trials

1

Recruited

40+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Findings from Research

Blood flow restriction (BFR) exercise can be safely performed by individuals with incomplete spinal cord injury (iSCI) without causing autonomic dysreflexia or deep vein thrombosis, as shown in a study with 9 participants.

The study found no significant differences in pain, perceived effort, or muscle activation between BFR and control exercises, indicating that BFR does not add extra cardiovascular strain while still promoting muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of Blood Flow Restriction Exercise in Patients With Incomplete Spinal Cord Injury. Stavres, J., Singer, TJ., Brochetti, A., et al.[2019]

Blood flow restriction (BFR) training at low loads (20% of 1RM) is effective in improving muscle strength in patients with chronic quadriceps and hamstring weakness, as demonstrated in a case series of seven patients with traumatic lower extremity injuries.

After 2 weeks of BFR therapy, all patients showed significant improvements in muscle strength metrics, with peak torque increasing by 13% to 37% and average power improving by 42% to 81%, indicating that BFR can be a valuable treatment for those who struggle with traditional rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction rehabilitation for extremity weakness: a case series. Hylden, C., Burns, T., Stinner, D., et al.[2022]

High-load resistance exercise (HL) resulted in significantly greater quadriceps muscle activation compared to low-load blood flow restriction training (BFRT) using both regulated and standardized devices, indicating that traditional strength training may be more effective for muscle activation.

Participants reported higher pain and perceived exertion during the regulated BFRT sessions compared to the standardized BFRT and high-load resistance exercise, suggesting that while BFRT can be effective, it may also be associated with greater discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of blood flow restriction devices and their effect on quadriceps muscle activation. Bordessa, JM., Hearn, MC., Reinfeldt, AE., et al.[2021]

In a study of 46 subjects over 8 weeks, both blood flow restriction (BFR) training and traditional exercise led to significant strength gains in the rotator cuff muscles, but there was no difference in strength improvements between the two methods.

Both groups also experienced increases in supraspinatus tendon thickness, indicating that low-load, high-repetition exercises can effectively enhance rotator cuff strength and tendon size, regardless of BFR application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training for the Rotator Cuff: A Randomized Controlled Trial. Brumitt, J., Hutchison, MK., Kang, D., et al.[2023]

A 12-week blood flow restriction (BFR) training program combined with low-intensity resistance training (LIRT) was well tolerated by a 54-year-old woman with multiple sclerosis (MS), showing measurable improvements in strength and functional goals without increasing fatigue.

The patient experienced significant improvements in 8 out of 14 strength tests and achieved her personal functional goals, suggesting that BFR/LIRT could be a beneficial training option for individuals with MS, although further research is needed to confirm its safety and effectiveness for the broader MS population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-Flow Restriction Training for a Person With Primary Progressive Multiple Sclerosis: A Case Report. Cohen, ET., Cleffi, N., Ingersoll, M., et al.[2021]

Blood flow-restricted resistance training (BFR-RT) is safe and effective for improving systolic blood pressure in patients with coronary artery disease (CAD), showing a significant reduction of 10 mm Hg after 8 weeks of training.

BFR-RT combined with aerobic training did not negatively affect hemostatic markers, indicating it can be a beneficial addition to cardiac rehabilitation programs without adverse effects on blood clotting factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial. Kambič, T., Novaković, M., Tomažin, K., et al.[2021]

Blood flow restriction training (BFRT) is generally safe for patients with musculoskeletal disorders, with a systematic review of 19 studies involving 322 participants showing that most did not report adverse events.

While some rare adverse events were noted, such as deep vein thrombosis and rhabdomyolysis, individuals undergoing BFRT did not experience more adverse events compared to those doing regular exercise, indicating its potential as a safe strengthening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Minniti, MC., Statkevich, AP., Kelly, RL., et al.[2020]

In a study involving 20 healthy participants, alternating (ALT) blood flow restriction (BFR) exercise resulted in significantly higher cardiovascular responses, including greater increases in aortic and mean arterial blood pressures compared to unilateral (UNI) and bilateral (BIL) patterns.

For individuals concerned about cardiovascular strain, unilateral or bilateral BFR exercises may be safer options than alternating patterns, as they produced lower cardiovascular responses during the exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute cardiovascular response to unilateral, bilateral, and alternating resistance exercise with blood flow restriction. Stanford, DM., Park, J., Jones, R., et al.[2021]

In a study involving 9 men with incomplete tetraplegia, neuromuscular electrical stimulation (NMES) combined with blood flow restriction (BFR) significantly increased the cross-sectional area (CSA) of wrist extensor muscles by 17% compared to NMES alone, indicating enhanced muscle growth.

The combination of NMES and BFR not only improved muscle size but also led to better wrist strength and hand function, with an acute increase in flow-mediated dilation (FMD) suggesting a potential mechanism for muscle hypertrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation and blood flow restriction increase wrist extensor cross-sectional area and flow meditated dilatation following spinal cord injury. Gorgey, AS., Timmons, MK., Dolbow, DR., et al.[2018]

In a study of 16 patients receiving electrical stimulation to various parts of the nervous system, 12 out of 13 patients experienced significant arterial dilation in their extremities, indicating improved blood flow.

Electrical stimulation applied to the ulnar nerves also resulted in arterial dilation, suggesting that this method can effectively enhance blood circulation in specific areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of blood flow to the extremities by electrical stimulation of the nervous system. Dooley, DM., Kasprak, M.[2019]

References

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

The Feasibility of Blood Flow Restriction Exercise in Patients With Incomplete Spinal Cord Injury. [2019]

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

Blood flow restriction rehabilitation for extremity weakness: a case series. [2022]

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

Comparison of blood flow restriction devices and their effect on quadriceps muscle activation. [2021]

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

Blood Flow Restriction Training for the Rotator Cuff: A Randomized Controlled Trial. [2023]

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

Blood-Flow Restriction Training for a Person With Primary Progressive Multiple Sclerosis: A Case Report. [2021]

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

Hemodynamic and Hemostatic Response to Blood Flow Restriction Resistance Exercise in Coronary Artery Disease: A Pilot Randomized Controlled Trial. [2021]

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

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Acute cardiovascular response to unilateral, bilateral, and alternating resistance exercise with blood flow restriction. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Electrical stimulation and blood flow restriction increase wrist extensor cross-sectional area and flow meditated dilatation following spinal cord injury. [2018]

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

Modification of blood flow to the extremities by electrical stimulation of the nervous system. [2019]