Spinal Cord Stimulation for Quadriplegia

Recruiting at 1 trial location

Overseen By Monica A Perez, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Antipsychotics, Tricyclic antidepressants

Disqualifiers: Pulmonary, Cardiovascular, Orthopedic, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 22

Duration: 4-7 weeks

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spinal cord stimulation can improve arm and hand movement in individuals with cervical spinal cord injuries. The study uses TESS (transcutaneous electrical spinal stimulation), a non-invasive technique to stimulate nerves and muscles. Participants include veterans with spinal injuries and healthy volunteers. The trial specifically seeks veterans who have had a spinal injury for over a year and can still visibly grip with one hand. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation techniques for spinal cord injuries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs that affect the central nervous system and lower the seizure threshold, like certain antipsychotics or tricyclic antidepressants.

What prior data suggests that this technique is safe for increasing limb function after spinal cord injury?

Research has shown that Transcutaneous Electrical Spinal Stimulation (TESS) is generally safe for people with spinal cord injuries. Studies have found that TESS is safe when combined with rehabilitation exercises, particularly for those with neck (cervical) spinal cord injuries. It is safe for most patients, except for those who might experience skin irritation where the electrodes are placed.

For instance, one study found that TESS did not cause any harmful effects on the heart or blood vessels. The treatment uses electrodes on the skin to send electrical signals to the spinal cord, which can help improve movement and recovery. Overall, evidence suggests TESS is well-tolerated and can support long-term recovery without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcutaneous electrical spinal stimulation (TESS) for quadriplegia because it offers a non-invasive approach to stimulate the spinal cord, potentially improving motor function in individuals with spinal cord injuries. Unlike traditional treatments that might focus more on physical therapy and assistive devices, TESS directly targets the cervical spinal cord to enhance neural activity. The unique aspect of this trial is the use of a closed-loop system in combination with intensive upper-limb training, which allows for real-time adjustments and may lead to more significant improvements in reaching and grasping abilities. This novel approach could lead to faster and more effective recovery compared to existing therapies.

What evidence suggests that TESS could be an effective treatment for quadriplegia?

Research has shown that Transcutaneous Electrical Spinal Stimulation (TESS), which participants in this trial may receive, can help individuals with spinal cord injuries regain muscle function. Studies have found that TESS can enhance grip strength and arm function following an injury to the neck area of the spine. This technique uses electrical pulses to stimulate the spinal cord, potentially aiding the body's natural rewiring process, known as neuroplasticity. Evidence suggests that TESS is safe and can effectively contribute to therapy for those with long-term spinal cord injuries, helping them regain some movement and strength. Participants in this trial may also receive sham-TESS as part of the study's comparator group. ^{3 4 5 6 7}

Who Is on the Research Team?

Monica Perez, PhD

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Are You a Good Fit for This Trial?

This trial is for male and female Veterans aged 18-70 with chronic spinal cord injury (SCI) at least one year old, specifically those who can grip with one hand and have a cervical injury above C8. Participants must not be pregnant, have debilitating diseases or major depression/psychosis, head injuries, uncontrolled medical issues, metal in the skull, history of seizures or drugs that lower seizure threshold.

Inclusion Criteria

We need to confirm that the electrodes will be placed on the injured part of the neck to treat the spinal cord injury.

I am a Veteran aged 18-70 with a spinal cord injury for over a year.

I have had a spinal cord injury for over a year.

Exclusion Criteria

I am taking medication that could increase my risk of seizures.

I have had a head injury, concussion, skull fracture, unexplained headaches in the last 6 months, or a stroke.

I have a history of seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Testing

Subjects participate in two testing sessions with TESS or sham-TESS applied over the cervical spinal cord.

1 week

2 visits (in-person)

Treatment

Participants undergo 20 sessions of TESS combined with massed practice upper-limb training.

4-7 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• sham-TESS
• TESS

Trial Overview The study tests TESS (transcutaneous electrical spinal stimulation), combined with motor training tasks to improve upper-limb function after SCI. It compares the effects of actual TESS versus sham (fake) treatment on muscle behavior and recovery potential in reaching/grasping movements.

How Is the Trial Designed?

Group I: Active TESS + Training Active Control 3 Interventions

Develop methodologies to promote recovery of reaching and grasping movements. To accomplish this goal, the investigators will combine TESS applied in a closed-loop manner with massed practice upper-limb training. Participants will be assigned to one of three groups in a randomized order for a controlled design: \[1) Closed-loop TESS applied during grasping + training, 2) Closed-loop TESS applied during reaching + training, and 3) Closed-loop TESS applied during grasping \& reaching + training.\] TESS for 20-min will be followed by 60 min of massed practice exercise training (total=20 sessions).

Group II: Active TESS Group 1 Active Control 3 Interventions

Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, active transcutaneous electrical spinal stimulation (TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

Group III: Sham TESS Group 1 Placebo Group 3 Interventions

Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, sham transcutaneous electrical spinal stimulation (sham-TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

TESS is already approved in United States, European Union for the following indications:

Approved in United States as TESS for:

• Spinal cord injury rehabilitation
• Tetraplegia management
• Upper limb function improvement

Approved in European Union as TESS for:

• Spinal cord injury rehabilitation
• Tetraplegia management
• Upper limb function improvement

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

In a pilot study involving 20 patients with idiopathic Restless Legs Syndrome (RLS) and 14 healthy subjects, transcutaneous spinal direct current stimulation (tsDCS) was shown to reduce symptoms of RLS, indicating its potential as a non-invasive treatment option.

Anodal stimulation specifically decreased spinal excitability, as measured by the H2/H1-ratio, and led to significant reductions in RLS symptoms, while sham stimulation had no effect, supporting the idea that spinal cord hyperexcitability contributes to RLS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. Heide, AC., Winkler, T., Helms, HJ., et al.[2018]

Trans-spinal direct current stimulation (tsDCS) has shown potential benefits, such as reducing hypertonia and neuropathic pain, particularly with anodal stimulation in patients with central nervous system diseases, based on a review of 8 studies involving 143 subjects.

The application of tsDCS was found to be feasible and safe, with no severe adverse effects reported, although the overall effectiveness remains uncertain due to variability in study results and the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-Spinal Direct Current Stimulation in Neurological Disorders: A systematic review. Fernández-Pérez, JJ., Serrano-Muñoz, D., Beltran-Alacreu, H., et al.[2023]

In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

Transcutaneous spinal Direct Current Stimulation (tsDCS) can effectively modulate interhemispheric motor connectivity, with anodal stimulation increasing interhemispheric delay and decreasing the duration of the ipsilateral Silent Period, indicating enhanced communication between brain hemispheres.

The study suggests that tsDCS could serve as a promising therapeutic tool for conditions involving impaired interhemispheric balance, offering a safe alternative for rehabilitation in patients with acute brain lesions when other non-invasive brain stimulation techniques may not be suitable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An unexpected target of spinal direct current stimulation: Interhemispheric connectivity in humans. Bocci, T., Caleo, M., Vannini, B., et al.[2022]

Transcutaneous spinal direct current stimulation (tsDCS) is a safe technique that can effectively modulate spinal cord excitability, as shown by changes in motor-evoked potentials (MEPs) in healthy subjects after stimulation.

The study found that cathodal tsDCS increased MEP amplitudes indicating enhanced inhibitory GABA(A)ergic drive, while anodal tsDCS had the opposite effect, suggesting tsDCS could be a promising rehabilitation strategy for patients with acute brain lesions or spinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. Bocci, T., Barloscio, D., Vergari, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6986544/

Transcutaneous Electrical Spinal Stimulation Promotes Long ... These data suggest that noninvasive electrical stimulation of spinal networks can promote neuroplasticity and long-term recovery following SCI.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... This study showed that tSCS combined with ABT is safe, feasible, and effective in adults with chronic SCI ranging from the cervical to thoracic level when ...

3. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... Improvements in upper extremity (UE) grip strength (11, 12) as well as UE function (11) have been reported in response to cervical TSCS, even in ...

4. nature.com nature.com/articles/s41394-020-00359-1

Feasibility and utility of transcutaneous spinal cord ... Conclusions. These results indicate that TSCS is clinically feasible and may be useful as an adjunct to walking-based therapy for adults with ...

5. e-neurospine.org e-neurospine.org/journal/view.php?doi=10.14245/ns.2244652.326

A Review of Functional Restoration From Spinal Cord ... This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8954138/

Trans-Spinal Electrical Stimulation Therapy for Functional ... It is a safe therapeutic tool which is also appropriate for all SCI patients except those with skin irritation [17]. Based on the stimulation ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000066

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.