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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based program combining special exercises (Blood Flow Restricted Exercise) and electrical stimulation (Transspinal Stimulation) to help individuals with quadriplegia (partial paralysis affecting all four limbs) improve movement and daily function. Researchers aim to determine if this program is more effective than exercises combined with a placebo version of the stimulation. The trial seeks participants who have had a spinal cord injury for over a year, specifically at the neck level or above, and can use telehealth tools like a computer and webcam. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance rehabilitation options for quadriplegia.

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 prior data suggests that this intervention is safe for individuals with tetraplegia?

Research shows that Blood Flow Restricted Exercise (BFRE) is generally safe for people with spinal cord injuries. Studies indicate that BFRE doesn’t increase the risk of blood clots in veins or cause significant changes in blood pressure. It also doesn’t put extra strain on the heart or cause more pain than usual.

Regarding Transspinal Stimulation (tSCS), research suggests it is safe and can help improve movement. Studies examining tSCS found it effective without major safety concerns.

Both treatments have been studied separately and appear safe. This suggests they are likely well-tolerated by people with spinal cord injuries, as indicated in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Blood Flow Restricted Exercise combined with Transspinal Stimulation for quadriplegia because it offers a novel approach to rehabilitation. Unlike traditional therapies that may focus on general physiotherapy and passive exercises, this method uses Blood Flow Restricted Exercise to enhance muscle activation even with limited movement ability. Additionally, Transspinal Stimulation targets the spinal cord directly to potentially improve motor function. This dual approach could lead to more effective muscle strengthening and better functional recovery for individuals with quadriplegia, offering hope for improved outcomes beyond existing therapies.

What evidence suggests that this trial's treatments could be effective for quadriplegia?

Studies have shown that Blood Flow Restricted Exercise (BFRE) is safe and effective for people with spinal cord injuries. It improves muscle strength without adding stress to the heart or body. Research also indicates that Transspinal Stimulation (TS) aids in motor recovery, potentially helping people regain movement. This trial will compare two treatment arms: one where participants receive Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) with sham TS, and another where participants receive BES with active TS. Together, these treatments may enhance movement and daily abilities in those with long-term tetraplegia. ^{1 4 5 6 7}

Who Is on the Research Team?

Ashraf Gorgey, MPT, PhD, FACSM, FACRM

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03690700

The Feasibility and Effects of Low-load Blood-flow ... The BFRE training protocol will be safe and applicable to individuals with a spinal cord injury; Participants randomized to active BFRE treatment will exhibit ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/sms.14759?af=R

Efficacy of Blood Flow Restriction Exercise for Improving ... The objective of the present study was to evaluate the efficacy of low-load (LL) blood flow restriction exercise (BFRE) for improving lower ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2024.2408052

Feasibility and safety of two weeks of blood flow restriction ... BFRE was feasible in an SCI rehabilitation setting despite a low recruitment rate. BFRE imposed no heightened risk of DVT or severe BP fluctuations.

4. mdpi.com mdpi.com/2227-9032/10/12/2407

Effectiveness of Blood Flow Restriction in Neurological ... There is scientific evidence that Blood Flow Restriction (BFR) is beneficial in healthy people, the elderly and patients with musculoskeletal disorders.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934148218302855

The Feasibility of Blood Flow Restriction Exercise in ... Results suggest that controlled BFR exercise can be safely performed by individuals with iSCI without added cardiovascular strain or heightened pain.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39392467/

Feasibility and safety of two weeks of blood flow restriction ... Conclusion: BFRE was feasible in an SCI rehabilitation setting despite a low recruitment rate. BFRE imposed no heightened risk of DVT or severe ...

7. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1496482/full

The effect of blood flow restriction training on core muscle ... Four weeks of LL-BFRT significantly reduced pain and functional disability while inducing similar strength gains as HL-RT in male collegiate athletes with ...