Noninvasive Spinal Stimulation for Stroke Recovery

Overseen By Sara Prokup, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Amphetamines, Lorazepam

Disqualifiers: Ataxia, Multiple strokes, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people regain balance and walking skills after a stroke. It tests spinal stimulation, a noninvasive technique that sends gentle electrical signals to the spinal nerves, either alone or with traditional walking exercises (conventional gait training). This approach may suit individuals who had a stroke at least six months ago, have walking difficulties requiring some support, and are not currently in regular physical therapy. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve stroke recovery options.

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 medications that affect motor system excitability, like amphetamines or lorazepam.

What prior data suggests that noninvasive spinal stimulation is safe for stroke recovery?

Research has shown that noninvasive spinal stimulation is generally safe. One study found that this method, when used during in-clinic rehabilitation, was well-tolerated and posed no significant risks to participants. Reports indicate that this technique can be safely applied in various settings and has shown promise in enhancing movement abilities.

Additionally, combining noninvasive spinal stimulation with walking exercises may improve walking skills. Studies have demonstrated that this combination is safe and could enhance the effectiveness of walking exercises, particularly for those recovering from a stroke. Participants tolerated the treatment well and experienced improvements in their walking. Overall, these findings suggest that this treatment is safe, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for stroke recovery because they explore noninvasive spinal stimulation as a novel way to enhance gait training. Unlike standard physical therapy or medication, this approach uses transcutaneous spinal cord stimulation to potentially improve motor function in stroke patients. This method is unique because it targets the spinal cord externally, without surgery, aiming to boost the brain's ability to relearn movement patterns. Additionally, combining this stimulation with traditional gait training could offer a synergistic effect, enhancing recovery outcomes more effectively than current options.

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

Research has shown that noninvasive spinal stimulation, a treatment under study in this trial, can improve walking in individuals with movement problems. One study found that it enhanced abilities like walking, particularly when combined with walking exercises. This trial includes a treatment arm where participants receive noninvasive spinal stimulation along with gait training. The stimulation sends electrical signals to the spinal cord, improving leg movement and balance. Another review noted that this method can help regain leg strength, crucial for walking after a stroke. Overall, early findings suggest that adding spinal stimulation to walking exercises might be more effective than exercises alone. ^{1 6 7 8 9}

Who Is on the Research Team?

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have hemiplegia from a stroke at least 6 months ago and need some help walking. They shouldn't be getting regular physical therapy, must have doctor's approval to join, and can't be pregnant or nursing. People with seizures unrelated to stroke, certain neurological conditions, severe muscle tightness in legs, recent Botox in the leg, metal implants in head/face or using heart devices like pacemakers are excluded.

Inclusion Criteria

I need someone's help to walk because of balance or coordination issues.

I am not currently undergoing regular physical therapy.

It has been over 6 months since my stroke.

Exclusion Criteria

I currently have a urinary tract infection.

You have a pacemaker implanted in your heart.

I do not have a brain injury or neurological condition affecting the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exploratory Phase

Identify optimal stimulation parameters and gait training protocol for each individual patient with stroke

4 weeks

Treatment

Participants undergo transcutaneous spinal cord stimulation and gait training to evaluate short-term and long-term effects on gait symmetry and performance

4 weeks

Multiple visits for interventions and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 3 months post-intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional gait training
• Exploratory Phase
• Noninvasive spinal stimulation
• Noninvasive spinal stimulation with gait training
• Sham

Trial Overview The study tests if non-invasive spinal cord stimulation improves walking and balance in people with hemiplegia after a stroke. It has two parts: one where participants try different methods one after another (cross-over), and another where they're randomly assigned to either get the real treatment or a pretend (sham) version.

How Is the Trial Designed?

Group I: Aim 2: Gait Training + Stimulation Experimental Treatment 2 Interventions

Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Group II: Aim 1: Gait Training + Stimulation Experimental Treatment 2 Interventions

Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Group III: Aim 1: Gait Training + Sham Stimulation Active Control 2 Interventions

Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Group IV: Aim 2: Gait Training + Sham Stimulation Active Control 2 Interventions

Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Conventional gait training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Conventional Gait Training for:

• Stroke Rehabilitation
• Hemiplegia
• Gait Disorders

Approved in European Union as Conventional Gait Training for:

• Stroke Rehabilitation
• Neurological Rehabilitation
• Physical Therapy

Approved in Canada as Conventional Gait Training for:

• Stroke Rehabilitation
• Hemiplegia
• Gait Disorders

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Transcutaneous electrical spinal cord stimulation (tSCS) can induce involuntary locomotor-like stepping movements in non-injured humans, suggesting its potential for rehabilitation.

Increasing the frequency of tSCS from 5 to 30 Hz enhances the amplitude of these stepping movements, indicating that tSCS effectively activates locomotor circuitry through the dorsal roots.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcutaneous electrical stimulation of the spinal cord: non-invasive tool for activation of locomotor circuitry in human]. Gorodnichev, RM., Pivovarova, EA., Pukhov, A., et al.[2012]

Transcutaneous electrical spinal cord stimulation (tSCS) effectively activates spinal networks to improve walking patterns in patients with hemiparesis, as demonstrated in a study involving patients 3-11 months post-stroke over a 2-week treatment period.

Patients receiving tSCS showed significant improvements in walking parameters compared to a control group that received sham stimulation, indicating that this technology can be a valuable tool in rehabilitation for locomotion disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Technology for Recovery of Locomotion in Patients after a Stroke. Moshonkina, TR., Zharova, EN., Ananev, SS., et al.[2023]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

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 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]

In a study involving 40 chronic stroke patients, both protocols of cerebellar transcranial direct current stimulation combined with robotic gait training resulted in significant improvements in walking ability, as measured by the 6-minute walk test, at all evaluation points.

There was no significant difference in walking improvements between the two stimulation protocols (contralesional vs. ipsilesional), suggesting that both approaches are equally effective in enhancing robotic gait training outcomes for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of two different protocols of cerebellar transcranial direct current stimulation combined with transcutaneous spinal direct current stimulation on robot-assisted gait training in patients with chronic supratentorial stroke: A single blind, randomized controlled trial. Picelli, A., Brugnera, A., Filippetti, M., et al.[2019]

A case study of a 27-year-old male with chronic spinal cord injury showed that combining locomotor training with multi-segmental spinal cord transcutaneous electrical stimulation (scTS) can enhance recovery of locomotion by reactivating dormant spinal networks.

After a 3-month training regimen, improvements in stepping coordination were observed, indicating that scTS may facilitate neuroplastic changes and better sensory-motor integration, which are crucial for functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Noninvasive Spinal Neuromodulation Strategy Facilitates Recovery of Stepping after Motor Complete Paraplegia. Siu, R., Brown, EH., Mesbah, S., et al.[2022]

Citations

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Noninvasive spinal stimulation improves walking in chronic ... This case series study aims to investigate the effectiveness of transcutaneous spinal cord stimulation (tSCS) in enhancing walking ability of persons with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11887137/

Non-invasive cerebral and spinal cord stimulation for motor ... In this review we aim to compare the effect of non-invasive cerebral and spinal cord stimulation on gait recovery and motor strength of lower limbs in subjects ...

3. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05591196

Hand and Arm Motor Recovery Via Non-invasive Electrical ... Growing evidence shows that electrical spinal cord stimulation, combined with activity-dependent rehabilitation, enables voluntary movement of paralyzed muscles ...

5. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(24)00111-9/fulltext

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11108781/

Non-invasive spinal cord electrical stimulation for arm and ... Here we conducted a prospective, single-arm, multicenter, open-label, non-significant risk trial that evaluated the safety and efficacy of ARCEX ...

7. neurology.org neurology.org/doi/10.1212/CPJ.0000000000200537

Home-Based Noninvasive Spinal Cord Stimulation Safely ... The Up-LIFT Trial demonstrated that in-clinic rehabilitation augmented by noninvasive spinal cord stimulation (ARCEX Therapy) safely and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924001119

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12560167/

Non-invasive spatiotemporal spinal neuromodulation ... This targeted spinal cord stimulation approach holds significant potential in gait rehabilitation post-stroke, offering a novel targeted ...