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

Trial Summary

What is the purpose of this trial?

This study has two interventional components, the first is a cross-over design and the second is a randomized control trial. Both will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.

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 data supports the effectiveness of this treatment for stroke recovery?

Research shows that transcutaneous electrical spinal cord stimulation (tSCS) can activate spinal networks to improve walking in stroke patients, as seen in a study where patients with hemiparesis showed clinically important improvements in walking after using tSCS. Additionally, similar noninvasive spinal stimulation techniques have been effective in enhancing motor recovery in spinal cord injury, suggesting potential benefits for stroke rehabilitation. ^{1 2 3 4 5}

Is noninvasive spinal stimulation safe for humans?

Research on transcutaneous electrical spinal cord stimulation (tSCS) suggests it is generally safe for humans, as it is a non-invasive method used in rehabilitation for various conditions, including stroke and spinal cord injuries. Studies have shown it can activate spinal circuits and improve motor functions without significant safety concerns. ^{1 2 3 6 7}

How does the treatment of noninvasive spinal stimulation for stroke recovery differ from other treatments?

Noninvasive spinal stimulation for stroke recovery is unique because it uses electrical stimulation to activate spinal networks that control walking, which can improve walking ability in stroke patients. This approach is non-invasive and targets the spinal cord directly, unlike traditional therapies that may focus on physical exercises alone. ^{1 2 3 5 6}

Research Team

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

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

A New Technology for Recovery of Locomotion in Patients after a Stroke. [2023]

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

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Noninvasive Spinal Neuromodulation Strategy Facilitates Recovery of Stepping after Motor Complete Paraplegia. [2022]

5. Netherlands 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. [2019]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Transcutaneous electrical stimulation of the spinal cord: non-invasive tool for activation of locomotor circuitry in human]. [2012]

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

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