Transspinal Stimulation + Locomotor Training for Spinal Cord Injury

Recruiting at 1 trial location

Overseen by Noam Y Harel, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: City University of New York

Must not be taking: Seizure threshold medications

Disqualifiers: Supraspinal lesions, Seizures, Pregnancy, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Locomotor training is often used with the aim to improve corticospinal function and walking ability in individuals with Spinal Cord Injury. Excitingly, the benefits of locomotor training may be augmented by noninvasive electrical stimulation of the spinal cord and enhance motor recovery at SCI. This study will compare the effects of priming locomotor training with high-frequency noninvasive thoracolumbar spinal stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of brain and spinal cord function will be performed before and after 40 sessions of locomotor training where spinal stimulation is delivered immediately before either lying down or during standing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people taking medications that may change the seizure threshold. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Transspinal Stimulation + Locomotor Training for Spinal Cord Injury?

Research shows that robotic-assisted gait training (RAGT) can significantly improve walking ability, leg strength, and mobility in people with spinal cord injuries, especially when started early. Additionally, combining robotic-assisted rehabilitation with non-invasive brain stimulation can further enhance motor function in the lower body. ^{1 2 3 4 5}

Is robotic-assisted gait training safe for people with spinal cord injury?

Research shows that robotic-assisted gait training (RAGT) is generally safe for people with spinal cord injury, as studies report no side effects during or after the training. ^{2 3 5 6 7}

How does the treatment Transspinal Stimulation + Locomotor Training for Spinal Cord Injury differ from other treatments?

This treatment is unique because it combines robotic gait training with transcutaneous spinal stimulation, which aims to enhance neuroplasticity (the brain's ability to reorganize itself) and improve walking function by reactivating dormant neural pathways in the spinal cord. Unlike traditional therapies, it uses electrical stimulation to modulate spinal networks, potentially leading to better recovery of movement and coordination. ^{8 9 10 11 12}

Research Team

Noam Y Harel, MD PhD

Principal Investigator

Bronx Veterans Medical Research Foundation

Maria Knikou, PT, PhD

Principal Investigator

Research Foundation of the City University of New York

Eligibility Criteria

This trial is for adults aged 18-70 with motor-incomplete spinal cord injury (SCI) above the T10 level, who can sign consent and commit to the study duration. They must be in good health, have a bone mineral density T-score <3.5 SD from norms, reflexes present for soleus H-reflex testing, flexible ankle joints without contractures, first-time SCI due to trauma or similar causes, and at least 6 months post-SCI.

Inclusion Criteria

You have had a spinal cord injury for more than 6 months.

In good general health as evidenced by medical history

I am between 18 and 70 years old.

Exclusion Criteria

I have a history of seizures.

I am not on medications that affect seizure risk.

I am not currently part of any research study or new rehab program.

Treatment Details

Interventions

• Robotic Gait Training (Behavioural Intervention)
• Transspinal Stimulation (Electrical Stimulation)

Trial Overview The study tests if high-frequency noninvasive thoracolumbar spinal stimulation before locomotor training improves walking ability in people with incomplete SCI. Participants will receive either real or sham stimulation while lying down or standing before robotic gait training over 40 sessions.

Participant Groups

Group I: Real transspinal stimulation delivered while lying supine followed by locomotor training Experimental Treatment 1 Intervention

Transspinal tonic stimulation will be delivered at a frequency of 30 Hz while lying supine.

Group II: Real transspinal stimulation delivered during standing followed by locomotor training Experimental Treatment 1 Intervention

Transspinal tonic stimulation of the thoracolumbar region will be delivered at a frequency of 30 Hz during standing with as needed body weight support (BWS) in a standing frame or in the Lokomat to ensure safety.

Group III: Sham transspinal stimulation delivered during standing followed by locomotor training Placebo Group 1 Intervention

One sham group will be receiving transspinal stimulation during standing at an intensity where sensation is absent.

Robotic Gait Training is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Robotic Assisted Gait Training for:

• Spinal cord injury
• Cerebral palsy
• Stroke
• Multiple sclerosis
• Parkinson’s disease

Approved in Switzerland as Robotic Assisted Gait Training for:

• Spinal cord injury
• Cerebral palsy
• Stroke
• Multiple sclerosis
• Parkinson’s disease

Who Is Running the Clinical Trial?

City University of New York

Lead Sponsor

Trials

23

Recruited

6,000+

Bronx Veterans Medical Research Foundation, Inc

Collaborator

Trials

10

Recruited

750+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Findings from Research

A review of studies on robot-assisted gait training for spinal cord injury patients found that while some improvements in body functions were noted, the evidence is insufficient to conclude that this method is more effective than traditional locomotor training due to small sample sizes and methodological issues.

The analysis included 6 trials with 43 patients, primarily using devices like the Lokomat, but highlighted the need for better-designed randomized controlled trials to establish the efficacy of robot-assisted training in improving walking ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of robot-assisted gait training in persons with spinal cord injury: a systematic review. Swinnen, E., Duerinck, S., Baeyens, JP., et al.[2022]

In a study involving 15 spinal cord injury patients, overground robotic gait training (Ekso GT) required higher energy expenditure and cognitive effort compared to treadmill robotic training (Lokomat), indicating a more demanding rehabilitation process.

Despite the increased effort, both robotic systems were well-received by patients, with improvements in walking economy observed, suggesting that both methods can be effective in enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy cost and psychological impact of robotic-assisted gait training in people with spinal cord injury: effect of two different types of devices. Corbianco, S., Cavallini, G., Dini, M., et al.[2021]

A network meta-analysis of 12 studies involving 353 participants with spinal cord injury found that wearable exoskeleton-assisted walking (EAW) significantly improved walking distance and speed compared to Lokomat training.

While both Lokomat and EAW enhanced locomotor abilities, EAW showed a higher probability of improving walking speed, suggesting it may be a more effective option for enhancing locomotion in individuals with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Efficacy of Lokomat and Wearable Exoskeleton-Assisted Gait Training in People With Spinal Cord Injury: A Systematic Review and Network Meta-Analysis. Zhang, L., Lin, F., Sun, L., et al.[2022]

Robot-assisted gait training (RAGT) significantly improves walking-related outcomes, such as gait distance and leg strength, in patients with incomplete spinal cord injury, especially during the acute phase of recovery, compared to over-ground training (OGT).

In chronic spinal cord injury patients, RAGT also enhances walking speed and balance more effectively than no intervention, suggesting it is a valuable rehabilitation technique for restoring mobility and promoting a healthier lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training (Lokomat) improves walking function and activity in people with spinal cord injury: a systematic review. Nam, KY., Kim, HJ., Kwon, BS., et al.[2020]

Combining robot-assisted rehabilitation (RAR) with non-invasive brain stimulation (NIBS) significantly improves lower extremity motor function in adults with incomplete spinal cord injury compared to RAR alone, as shown by greater improvements in tests like the 10 m walk test and the Functional Independence Measure-Locomotion.

No adverse effects were reported during the trial, indicating that the combined approach of RAR and NIBS is safe for participants, but further research with larger groups is needed to explore long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding the Way to Improve Motor Recovery of Patients with Spinal Cord Lesions: A Case-Control Pilot Study on a Novel Neuromodulation Approach. Naro, A., Billeri, L., Balletta, T., et al.[2023]

In a study involving 12 patients with chronic spinal cord injury, both standard rehabilitation and robot-assisted gait training (RAGT) led to increased self-selected walking speed, indicating short-term efficacy in improving gait functions.

RAGT specifically contributed to a significant increase in step length, which was associated with improved hip flexor muscle function, highlighting its potential as a beneficial intervention in rehabilitation for SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training using a wearable robotic hip device for incomplete spinal cord injury: A preliminary study. Yoshikawa, K., Mutsuzaki, H., Koseki, K., et al.[2023]

A new functional electrical stimulation (FES) system was developed that adapts stimulation timing based on the position of the hindlimb during stepping in a rodent model of spinal cord injury, which is an improvement over traditional fixed-timing FES systems.

This innovative system aims to enhance rehabilitation by promoting spinal plasticity, potentially leading to better recovery outcomes for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A system to integrate electrical stimulation with robotically controlled treadmill training to rehabilitate stepping after spinal cord injury. Chao, T., Askari, S., De Leon, R., et al.[2012]

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 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]

Epidural spinal cord stimulation can activate spared neural circuitry below severe spinal cord injuries, enabling paralyzed individuals to achieve motor outputs like standing and stepping during assisted treadmill exercises.

This stimulation not only generates immediate motor responses but also supports rehabilitation by promoting long-term neural plasticity, potentially leading to lasting improvements in motor function for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. Minassian, K., Hofstoetter, US.[2020]

In a study of nine individuals with chronic motor-incomplete spinal cord injury, continuous lumbosacral transcutaneous spinal stimulation (TSS) at varying frequencies showed diverse effects on robotic torques and muscle activity during robotic gait training.

The results indicated that higher stimulation frequencies generally led to greater changes in robotic torques and reduced muscle activity in some participants, while others exhibited increased muscle activity at mid-frequency ranges, highlighting the need for personalized approaches in TSS therapy for gait improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation with transcutaneous spinal stimulation reveals different groups of motor profiles during robot-guided stepping in humans with incomplete spinal cord injury. Krenn, MJ., White, JM., Stokic, DS., et al.[2023]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Effectiveness of robot-assisted gait training in persons with spinal cord injury: a systematic review. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Energy cost and psychological impact of robotic-assisted gait training in people with spinal cord injury: effect of two different types of devices. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Efficacy of Lokomat and Wearable Exoskeleton-Assisted Gait Training in People With Spinal Cord Injury: A Systematic Review and Network Meta-Analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training (Lokomat) improves walking function and activity in people with spinal cord injury: a systematic review. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Finding the Way to Improve Motor Recovery of Patients with Spinal Cord Lesions: A Case-Control Pilot Study on a Novel Neuromodulation Approach. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Gait training using a wearable robotic hip device for incomplete spinal cord injury: A preliminary study. [2023]

7. India pubmed.ncbi.nlm.nih.gov

Gait Training with Robotic Exoskeleton Assisted Rehabilitation System in Patients with Incomplete Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study and Review of Literature. [2023]

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

A system to integrate electrical stimulation with robotically controlled treadmill training to rehabilitate stepping after spinal cord injury. [2012]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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

10. 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]

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

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. [2020]

12. Germany pubmed.ncbi.nlm.nih.gov

Neuromodulation with transcutaneous spinal stimulation reveals different groups of motor profiles during robot-guided stepping in humans with incomplete spinal cord injury. [2023]