Non-Invasive Spinal Cord Stimulation for Neurological Disorders

Overseen By Siddhi R Shrivastav, BPTh, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anticoagulants, Osteoporosis meds

Disqualifiers: Hypertension, Seizures, Cancer, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate whether non-invasive stimulation over the spinal cord at the neck and/or lower back can improve walking function for people with neurologic conditions. Spinal stimulation has been used extensively for individuals with spinal cord injury, and has demonstrated improvements in function. This study will extend this work to other neurologic conditions, such as cerebral palsy and stroke, that also demonstrate similar impairments as spinal cord injury. The primary aims of this study are to: Aim 1: Evaluate impact of spinal stimulation on spasticity and locomotor function. Aim 2: Investigate participant perceptions of spinal stimulation. The investigators will be using a cross-over design study to compare intensive training only to intensive training combined with spinal stimulation. After an initial baseline period of up to 4 weeks (Phase I). Participants will have their first intervention phase of the study (Phase II). This will involve either intensive training only (Condition A) or intensive training combined with spinal stimulation (Condition B). This will be followed by a washout period with no intervention (Phase III) and then the second intervention phase (Phase IV). The second intervention phase will involve either Condition A or Condition B, whichever the participants did not received during Phase II. Phases II-IV will each last up to 8 weeks. After the intervention period is complete, the participant will be asked to come for follow-up visits up to 3 months after the intervention phases are completed (Phase V).

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have an implanted stimulator or drug delivery device, you cannot participate in the trial.

What data supports the effectiveness of the treatment Non-Invasive Spinal Cord Stimulation for Neurological Disorders?

Research shows that combining locomotor training with transcutaneous spinal stimulation (TSS) can improve walking speed and distance in people with spinal cord injuries. Although improvements in spasticity (muscle stiffness) were not significant, TSS is a feasible addition to enhance walking outcomes during rehabilitation. ^{1 2 3 4 5}

Is non-invasive spinal cord stimulation safe for humans?

Research suggests that non-invasive spinal cord stimulation, often combined with locomotor training, is generally safe for humans. Studies have shown it to be a feasible treatment option with no significant adverse effects reported, making it a promising approach for improving motor functions in conditions like spinal cord injury and cerebral palsy. ^{1 6 7 8 9}

How is Gait Training different from other treatments for neurological disorders?

Gait Training, combined with non-invasive spinal cord stimulation, is unique because it uses painless electrical stimulation to modulate the spinal cord's neural circuits, enhancing stepping movements and motor control without the need for invasive procedures. This approach can improve locomotor function even in individuals with severe spinal cord injuries, offering a novel way to rehabilitate sensorimotor function. ^{9 10 11 12 13}

Research Team

Katherine M Steele, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for people with neurological conditions like cerebral palsy who can walk 20 yards and follow simple instructions. They must be medically stable, able to attend up to five therapy sessions weekly, and have support for the 11-month study period. Those with severe medical issues, uncontrolled seizures, recent musculoskeletal surgeries, or implanted devices are excluded.

Inclusion Criteria

I can attend up to 5 physical therapy sessions weekly.

My health condition is stable.

I can follow simple instructions and perform basic tasks.

Exclusion Criteria

My cancer is currently active.

I have a heart or muscle condition that stops me from fully joining in physical therapy.

You need help breathing from a machine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial baseline period to assess participants before intervention

up to 4 weeks

First Intervention

Participants undergo either intensive training only or intensive training combined with spinal stimulation

up to 8 weeks

Washout

A period with no intervention to eliminate effects of the first intervention

up to 8 weeks

Second Intervention

Participants undergo the intervention they did not receive during the first intervention phase

up to 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 12 weeks

Treatment Details

Interventions

• Gait Training
• Transcutaneous Spinal Stimulation

Trial Overview The study tests if non-invasive spinal stimulation combined with gait training improves walking in neurologic conditions. It's a cross-over design where participants first get only training or training plus stimulation, then switch after a break period. Each phase lasts up to 8 weeks with follow-ups for three months.

Participant Groups

Group I: Intensive Training Only Active Control 1 Intervention

Physical and gait training that targets rehabilitation of walking function.

Group II: Intensive Training Combined with Spinal Stimulation Active Control 2 Interventions

Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function.

Gait Training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gait Training for:

• Spinal Cord Injury
• Cerebral Palsy
• Stroke Rehabilitation

Approved in European Union as Gait Training for:

• Spinal Cord Injury
• Neurological Rehabilitation

Approved in Canada as Gait Training for:

• Spinal Cord Injury
• Stroke Rehabilitation

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

Findings from Research

In a study involving 18 individuals with subacute motor-incomplete spinal cord injury, combining locomotor training (LT) with transcutaneous spinal stimulation (TSS) showed promising improvements in walking speed and distance after a 4-week program, although no significant differences were found between the TSS and sham groups.

The results suggest that TSS is a feasible addition to LT during rehabilitation, potentially enhancing walking outcomes, but did not significantly affect spasticity, possibly due to high variability in spasticity measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Transcutaneous Spinal Stimulation and Locomotor Training to Improve Walking Function and Reduce Spasticity in Subacute Spinal Cord Injury: A Randomized Study of Clinical Feasibility and Efficacy. Estes, S., Zarkou, A., Hope, JM., et al.[2022]

Robot-assisted gait training (RAGT) combined with non-invasive brain stimulation (NIBS) significantly improved lower limb function in patients with stroke and spinal cord injury, based on a meta-analysis of five studies involving 104 participants.

However, the combination did not show a significant improvement in lower limb activities, and there was no difference in effectiveness between RAGT with tDCS and sham stimulation, indicating that while RAGT with NIBS is beneficial, the type of NIBS may not enhance outcomes further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of robot-assisted gait training combined with non-invasive brain stimulation on lower limb function in patients with stroke and spinal cord injury: A systematic review and meta-analysis. Kuwahara, W., Sasaki, S., Yamamoto, R., et al.[2022]

Non-invasive brain and spinal cord stimulation techniques have been shown to effectively support recovery of gait, balance, and lower limb motor function in stroke patients, based on a systematic review of 25 studies involving 657 participants.

Transcranial and trans-spinal direct current/alternating current stimulation are more effective than repetitive transcranial magnetic stimulation, and bilateral stimulation yields better results than unilateral stimulation, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation for improving gait, balance, and lower limbs motor function in stroke. Veldema, J., Gharabaghi, A.[2022]

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]

A study involving 7 spinal cord injured patients and 10 healthy controls demonstrated that early treadmill training can be safely performed without supportive orthoses, maintaining joint motion within normal physiological limits.

After training, patients showed significant improvements in walking speed and duration, indicating that treadmill training can enhance mobility and endurance in individuals with spinal cord injuries while minimizing the risk of injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait analysis on the treadmill - monitoring exercise in the treatment of paraplegia. Abel, R., Schablowski, M., Rupp, R., et al.[2011]

In a study involving 64 participants with chronic motor-incomplete spinal cord injury, overground locomotor training showed a strong positive correlation between the amount of training (distance and time) and improvements in walking distance and speed.

In contrast, treadmill-based training methods did not demonstrate significant relationships between training dose and walking outcomes, suggesting that overground training may be more effective for enhancing walking function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Response Outcomes Associated with Different Forms of Locomotor Training in Persons with Chronic Motor-Incomplete Spinal Cord Injury. Sandler, EB., Roach, KE., Field-Fote, EC.[2019]

Intermittent electrical stimulation for 1-2 hours daily can significantly enhance muscle strength and endurance, and even reverse some osteoporosis in bones affected by spinal cord injury.

In a multicenter study, participants experienced nearly a 20% increase in walking speed initially, with sustained improvements of almost 50% after a year of continued stimulation, indicating both immediate and long-term benefits of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation after spinal cord injury. Stein, RB.[2006]

In a study involving 28 participants with spastic cerebral palsy, transcutaneous spinal cord stimulation combined with locomotor treadmill training significantly improved knee torque compared to treadmill training alone.

The experimental group also showed a greater reduction in co-activation of hip and lower extremity muscles, suggesting that spinal stimulation enhances locomotor function more effectively than training alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of spinal cord stimulation on motor functions in children with cerebral palsy. Solopova, IA., Sukhotina, IA., Zhvansky, DS., et al.[2018]

Epidural electrical stimulation (EES) can be effectively used to improve motor control and locomotion in rats and nonhuman primates, with stable implants that last for several months.

The described protocols allow for precise control of leg movements during locomotion by delivering timed stimulation bursts to specific spinal cord locations, enabling real-time feedback and adaptation for enhanced motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Configuration of electrical spinal cord stimulation through real-time processing of gait kinematics. Capogrosso, M., Wagner, FB., Gandar, J., et al.[2021]

A novel non-invasive technique called painless transcutaneous electrical enabling motor control (pcEmc) can effectively stimulate spinal cord circuits to facilitate stepping movements in healthy individuals, showing promise for neuromodulation.

When combined with exoskeleton technology, pcEmc has demonstrated effectiveness in improving motor function in paralyzed patients with spinal cord injuries, highlighting its potential for rehabilitation and understanding locomotion mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical spinal-cord stimulation in humans. Gerasimenko, Y., Gorodnichev, R., Moshonkina, T., et al.[2018]

Targeted spinal cord stimulation allowed individuals with spinal cord injuries, who had been paralyzed for over four years, to regain voluntary control of their leg movements within a week of treatment.

Participants showed significant improvements in walking ability and could perform activities like walking or cycling in real-world settings after months of rehabilitation, demonstrating the potential of this technology for enhancing recovery and daily living post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted neurotechnology restores walking in humans with spinal cord injury. Wagner, FB., Mignardot, JB., Le Goff-Mignardot, CG., et al.[2021]

In a study of 8 patients with spinal cord stimulation (SCS) devices for chronic pain, significant improvements in posture and gait were observed when the SCS was turned ON, as measured by clinical scales and 3D gait analysis.

The improvements in gait and trunk movement were not present when the SCS was OFF, suggesting that SCS may provide a pain-free opportunity to enhance rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation in Failed Back Surgery Syndrome: Effects on Posture and Gait-A Preliminary 3D Biomechanical Study. Brugliera, L., De Luca, A., Corna, S., et al.[2018]

Transcutaneous electrical spinal cord stimulation can enhance locomotor function in patients with movement disorders, as evidenced by involuntary leg movements resembling normal locomotion during stimulation at frequencies of 5 and 30 Hz.

The study involved 10 patients aged 32 to 70 with varying degrees of locomotor impairment due to brain or spinal cord injuries, and it was found that stimulation increased excitability in spinal neural structures, indicating a potential therapeutic approach for improving movement in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The influence of non-invasive electrical stimulation of the spinal cord on the locomotor function of patients presenting with movement disorders of central genesis]. Balykin, MV., Yakupov, RN., Mashin, VV., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Combined Transcutaneous Spinal Stimulation and Locomotor Training to Improve Walking Function and Reduce Spasticity in Subacute Spinal Cord Injury: A Randomized Study of Clinical Feasibility and Efficacy. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The effects of robot-assisted gait training combined with non-invasive brain stimulation on lower limb function in patients with stroke and spinal cord injury: A systematic review and meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation for improving gait, balance, and lower limbs motor function in stroke. [2022]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Gait analysis on the treadmill - monitoring exercise in the treatment of paraplegia. [2011]

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

Dose-Response Outcomes Associated with Different Forms of Locomotor Training in Persons with Chronic Motor-Incomplete Spinal Cord Injury. [2019]

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

Functional electrical stimulation after spinal cord injury. [2006]

8. Ireland pubmed.ncbi.nlm.nih.gov

Effects of spinal cord stimulation on motor functions in children with cerebral palsy. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Configuration of electrical spinal cord stimulation through real-time processing of gait kinematics. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical spinal-cord stimulation in humans. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Targeted neurotechnology restores walking in humans with spinal cord injury. [2021]

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

Spinal Cord Stimulation in Failed Back Surgery Syndrome: Effects on Posture and Gait-A Preliminary 3D Biomechanical Study. [2018]

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

[The influence of non-invasive electrical stimulation of the spinal cord on the locomotor function of patients presenting with movement disorders of central genesis]. [2018]