Standing transspinal stimulation followed by robotic gait training for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord Injuries+5 More
Standing transspinal stimulation followed by robotic gait training - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the effects of adding electrical stimulation to locomotor training to help improve walking ability in people with Spinal Cord Injury.

Eligible Conditions
  • Spinal Cord Injuries
  • Quadriplegia
  • Spastic Paraplegia
  • Paraplegia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 4 years

4 years
Ambulatory function
Autonomic function
Balance
Plasticity of corticospinal networks
Plasticity of spinal neuronal networks

Trial Safety

Trial Design

3 Treatment Groups

Real transspinal stimulation delivered during standing followed by locomotor tra...
1 of 3
Real transspinal stimulation delivered while lying supine followed by locomotor ...
1 of 3
Sham transspinal stimulation delivered during standing followed by locomotor tra...
1 of 3

Experimental Treatment

Non-Treatment Group

45 Total Participants · 3 Treatment Groups

Primary Treatment: Standing transspinal stimulation followed by robotic gait training · Has Placebo Group · N/A

Real transspinal stimulation delivered during standing followed by locomotor training
CombinationProduct
Experimental Group · 1 Intervention: Standing transspinal stimulation followed by robotic gait training · Intervention Types: CombinationProduct
Real transspinal stimulation delivered while lying supine followed by locomotor training
CombinationProduct
Experimental Group · 1 Intervention: Lying transspinal stimulation followed by robotic gait training · Intervention Types: CombinationProduct
Sham transspinal stimulation delivered during standing followed by locomotor training
Other
ShamComparator Group · 1 Intervention: Standing sham transspinal stimulation followed by robotic gait training · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

Bronx Veterans Medical Research Foundation, IncOTHER
8 Previous Clinical Trials
756 Total Patients Enrolled
3 Trials studying Spinal Cord Injuries
122 Patients Enrolled for Spinal Cord Injuries
City University of New YorkLead Sponsor
10 Previous Clinical Trials
4,719 Total Patients Enrolled
1 Trials studying Spinal Cord Injuries
10 Patients Enrolled for Spinal Cord Injuries
Icahn School of Medicine at Mount SinaiOTHER
771 Previous Clinical Trials
479,781 Total Patients Enrolled
9 Trials studying Spinal Cord Injuries
898 Patients Enrolled for Spinal Cord Injuries
Maria Knikou, PT, PhDPrincipal Investigator - Research Foundation of the City University of New York
City University of New York
2 Previous Clinical Trials
24 Total Patients Enrolled
2 Trials studying Spinal Cord Injuries
24 Patients Enrolled for Spinal Cord Injuries
Noam Y. Harel, MD, PhDPrincipal InvestigatorBronx Veterans Medical Research Foundation
3 Previous Clinical Trials
69 Total Patients Enrolled
3 Trials studying Spinal Cord Injuries
69 Patients Enrolled for Spinal Cord Injuries

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an incomplete spinal cord injury (AIS C-D).
You have a tendon reflex to the soleus muscle.
You have a lesion above thoracic (T) 10.
You have no permanent ankle joint contractures that prevent passive or active ankle movement because corticospinal and spinal excitability is based on the ankle angle
You have a first time SCI due to trauma, vascular, or orthopedic pathology.
You are female or male, age 18-70 years old.
You have low bone mineral density of the hip.\n
You are willing to comply with all study procedures and are available for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References