Stroke > Conventional Gait Training

Noninvasive Spinal Stimulation for Stroke Recovery

Recruiting in Palo Alto (17 mi)

Overseen By Arun Jayaraman, PT, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Shirley Ryan AbilityLab

No Placebo Group

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.

Is the treatment Noninvasive Spinal Stimulation with gait training promising for stroke recovery?

Yes, Noninvasive Spinal Stimulation with gait training is promising for stroke recovery. It helps improve walking by activating spinal networks that control movement, and studies show it can enhance walking abilities in stroke patients.^{1 2 3 5 7}

What safety data exists for noninvasive spinal stimulation in stroke recovery?

The safety data for noninvasive spinal stimulation, including transcutaneous electrical spinal cord stimulation (tSCS), suggests it is a non-invasive method that can activate locomotor circuitry and improve walking in patients with locomotion disorders, such as those recovering from a stroke. Studies have shown that tSCS can induce involuntary locomotor-like movements and improve walking parameters in patients with hemiparesis post-stroke. Additionally, tSCS has been used in spinal cord injury rehabilitation, indicating its potential safety and efficacy in modulating motor responses and improving motor recovery. However, specific safety outcomes and adverse effects are not detailed in the provided abstracts, suggesting the need for further research to comprehensively assess safety.^{1 3 4 5 7}

What data supports the idea that Noninvasive Spinal Stimulation for Stroke Recovery is an effective treatment?

The available research shows that Noninvasive Spinal Stimulation, specifically using transcutaneous electrical spinal cord stimulation (tSCS), can improve walking in stroke patients. In a study, patients who received this treatment showed significant improvements in their walking abilities compared to those who received a sham (fake) version of the treatment. This suggests that the treatment is effective in helping stroke patients regain better control over their walking.^{2 3 5 6 7}

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications that affect motor system excitability, like amphetamines or lorazepam, you may be excluded from certain parts of the study.

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.

I have paralysis on one side of my body due to a stroke.

Exclusion Criteria

I currently have a urinary tract infection.

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

I have pain in my muscles or joints due to recent injuries or infections.

I have a medical condition that makes it hard for me to walk.

I have a bone fracture that has not yet healed.

I do not have uncontrolled heart, lung, or metabolic conditions.

I have severe stiffness in my legs that limits movement.

I have nerve damage in my hands or feet.

I have active pressure sores.

I have a leg condition that affects my ability to walk or move.

My cancer is active or has been in remission for less than 5 years.

I have metal implants in my head or face.

I have had more than one stroke.

I have had skull abnormalities or fractures.

I have had seizures not caused by a stroke, or I have epilepsy.

I have difficulty coordinating my movements.

My leg stiffness is severe, scoring 3 or more.

Participant Groups

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.

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: Stimulation Only Active Control 2 Interventions

Up to 60 minutes of transcutaneous spinal cord stimulation while resting in a comfortable position.

Group IV: 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 V: 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.

Group VI: Aim 1: Sham Only Placebo Group 2 Interventions

Up to 60 minutes of transcutaneous spinal cord stimulation while resting in a comfortable position during which they will receive up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention.

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

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Shirley Ryan AbilityLab Chicago, IL

Who is running the clinical trial?

Shirley Ryan AbilityLab Lead Sponsor

University of California, Los Angeles Collaborator

References

1. 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] A new tool for locomotor circuitry activation in the non-injured human by transcutaneous electrical spinal cord stimulation (tSCS) has been described. We show that continuous tSCS over T11-T12 vertebrae at 5-40 Hz induced involuntary locomotor-like stepping movements in subjects with their legs in a gravity-independent position. The increase of frequency of tSCS from 5 to 30 Hz augmented the amplitude of evoked stepping movements. The duration of cycle period did not depend on frequency of tSCS. During tSCS the hip, knee and ankle joints were involved in the stepping performance. It has been suggested that tSCS activates the locomotor circuitry through the dorsal roots. It appears that tSCS can be used as a non-invasive method in rehabilitation of spinal pathology.

2. 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] The neural organization of locomotion involves motor patterns generated by spinal interneuronal networks and supraspinal structures, which are approachable by noninvasive stimulation techniques. Recent evidences supported the hypothesis that transcranial direct current stimulation (combined with transcutaneous spinal direct current stimulation) may actually enhance the effects of robot-assisted gait training in chronic stroke patients. The cerebellum has many connections to interact with neocortical areas and may provide some peculiar plasticity mechanisms. So, it has been proposed as "non-lesioned entry" to the motor or cognitive system for the application of noninvasive stimulation techniques in patients with supratentorial stroke.

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

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021] Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive method of stimulating spinal circuits that can modulate and induce changes in corticospinal excitability (CE) in incomplete spinal cord injury (SCI). A double-blinded sham controlled study of 2 male patients (A and B) with SCI was carried out. Patient A received sham and cathodal tsDCS, while Patient B received sham and anodal tsDCS. Four baselines were recorded prior to each arm of stimulation. Outcomes were then measured post each arm of stimulation; 10-meter walk test, modified ashworth scale, berg balance scale, manual muscle testing, and spinal cord independence measure-III. Transcranial magnetic stimulation, assessed motor evoked potentials. Cathodal tsDCS increased the scores in few of the outcome measures and decreased others. Anodal stimulation increased scores in all measures. Motor evoked potentials increased in post-cathode and deteriorated in post-anode. In conclusion, tsDCS modulated gait parameters, spasticity, and CE in incomplete SCI.

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022] Transcutaneous spinal cord stimulation (tSCS) is a non-invasive modality in which electrodes can stimulate spinal circuitries and facilitate a motor response. This review aimed to evaluate the methodology of studies using tSCS to generate motor activity in persons with spinal cord injury (SCI) and to appraise the quality of included trials.

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

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022] Cervical transcutaneous spinal cord stimulation (tSCS) is a rehabilitation tool which has been used to promote upper-limb motor recovery after spinal cord injury. Importantly, optimizing sensory fiber activation at specific spinal segments could enable activity-dependent neuromodulation during rehabilitation.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Noninvasive Spinal Neuromodulation Strategy Facilitates Recovery of Stepping after Motor Complete Paraplegia. [2022] It has been suggested that neuroplasticity-promoting neuromodulation can restore sensory-motor pathways after spinal cord injury (SCI), reactivating the dormant locomotor neuronal circuitry. We introduce a neuro-rehabilitative approach that leverages locomotor training with multi-segmental spinal cord transcutaneous electrical stimulation (scTS). We hypothesized that scTS neuromodulates spinal networks, complementing the neuroplastic effects of locomotor training, result in a functional progression toward recovery of locomotion. We conducted a case-study to test this approach on a 27-year-old male classified as AIS A with chronic SCI. The training regimen included task-driven non-weight-bearing training (1 month) followed by weight-bearing training (2 months). Training was paired with multi-level continuous and phase-dependent scTS targeting function-specific motor pools. Results suggest a convergence of cross-lesional networks, improving kinematics during voluntary non-weight-bearing locomotor-like stepping. After weight-bearing training, coordination during stepping improved, suggesting an important role of afferent feedback in further improvement of voluntary control and reorganization of the sensory-motor brain-spinal connectome.

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

A New Technology for Recovery of Locomotion in Patients after a Stroke. [2023] Neural networks in the spinal cord can generate the walking pattern and control posture in the absence of supraspinal influences. A technology using transcutaneous electrical spinal cord stimulation (tSCS) was created. During walking, tSCS activated spinal locomotor networks, as well as leg flexor/extensor motor pools in the swing/stance phases, respectively. It was assumed that the use of this technology in subjects with locomotion disorders would improve walking. Patients with hemiparesis were studied 3-11 months after stroke, the duration of the course was 2 weeks. Patients of the main and control groups received standard therapy and rehabilitation using the technology; in the control group, sham tSCS was used. After the course, minimal clinically important differences in walking parameters were achieved in the main group, in contrast to the control group. The developed technology is an effective means of restoring walking in patients with hemiparesis.