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

Trial Summary

What is the purpose of this trial?

In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.

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 data supports the effectiveness of the treatment for quadriplegia?

Research shows that transcutaneous spinal direct current stimulation (tsDCS) can improve movement and reduce muscle stiffness in people with incomplete spinal cord injuries. This suggests that similar treatments might help those with quadriplegia by enhancing spinal cord activity and motor responses. ^{1 2 3 4 5}

Is spinal cord stimulation safe for humans?

Research indicates that transcutaneous spinal direct current stimulation (tsDCS) is generally considered a safe technique for modulating spinal cord activity in humans. ^{1 2 3 5 6}

How is the treatment TESS different from other treatments for quadriplegia?

TESS (Transcutaneous Electrical Spinal Cord Stimulation) is unique because it is a non-invasive treatment that uses electrical currents applied through the skin to stimulate the spinal cord, potentially improving motor function in individuals with spinal cord injuries. Unlike other treatments that may require surgery or medication, TESS directly targets spinal circuits to facilitate motor responses without the need for invasive procedures. ^{1 2 3 4 5}

Research Team

Monica Perez, PhD

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

An unexpected target of spinal direct current stimulation: Interhemispheric connectivity in humans. [2022]

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

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. [2022]

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

Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. [2018]

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

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

Trans-Spinal Direct Current Stimulation in Neurological Disorders: A systematic review. [2023]