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

Phase-Based Estimates
1
Effectiveness
1
Safety
Veterans Affairs Medical Center, Bronx, NY
Spinal Cord Injuries+5 More
Standing transspinal stimulation followed by robotic gait training - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Spinal Cord Injuries

Study Summary

This study is evaluating whether a type of electrical stimulation may help improve walking ability in individuals with spinal cord injury.

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Eligible Conditions

  • Spinal Cord Injuries
  • Paraplegia
  • Quadriplegia
  • Spastic Paraplegia
  • Paraplegia, Spinal
  • Tetraplegia/Tetraparesis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Standing transspinal stimulation followed by robotic gait training will improve 2 primary outcomes and 3 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of 4 years.

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

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Sham transspinal stimulation delivered during standing followed by locomotor training
Real transspinal stimulation delivered during standing followed by locomotor training
Placebo group

This trial requires 45 total participants across 3 different treatment groups

This trial involves 3 different treatments. Standing Transspinal Stimulation Followed By Robotic Gait Training is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Real transspinal stimulation delivered during standing followed by locomotor training
CombinationProduct
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.
Real transspinal stimulation delivered while lying supine followed by locomotor training
CombinationProduct
Transspinal tonic stimulation will be delivered at a frequency of 30 Hz while lying supine.
Sham transspinal stimulation delivered during standing followed by locomotor training
Other
One sham group will be receiving transspinal stimulation during standing at an intensity where sensation is absent.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Who is running the study

Principal Investigator
M. K.
Prof. Maria Knikou,, PhD
City University of New York

Closest Location

Veterans Affairs Medical Center - Bronx, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Ability to understand the consent form, and sign the consent form.
Male or female, age 18-70 years old.
In good general health as evidenced by medical history.
Diagnosed with motor incomplete SCI (AIS C-D).
Bone mineral density of the hip (proximal femur) T-score <3.5 SD from age- and gender-matched normative data.
Presence of tendon reflexes to be able to elicit the soleus H-reflex.
Willingness to comply with all study procedures and availability for the duration of the study.
Lesion above thoracic (T) 10 to ensure absent lower motoneuron lesion.
Absent permanent ankle joint contractures that prevent passive or active ankle movement because corticospinal and spinal excitability is based on the ankle angle. The ankle straps of the Lokomat require also flexible ankle joints.
A diagnosis of first time SCI due to trauma, vascular, or orthopedic pathology.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who should consider clinical trials for spinal cord injuries?

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Subjects with spinal cord injuries without a history of epidural steroid injections have a similar neurologic outcome to those without spinal cord injuries on the [SF-36].

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What causes spinal cord injuries?

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Cervical spine trauma is the most common type of traumatic [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) and causes symptoms and disabilities in approximately 5% of traumatic spinal cord injuries. Cervical injuries usually result in paralysis, incontinence, or impotence due to damage to the motor and sensory nerves. Spinal cord injuries can be prevented by the use of seat belts and car accident prevention measures. The cervical spine has many potential sites for spinal cord injuries, so the number of cervical cord injuries is high. A cervical collar, or neck brace, may help prevent injury.

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How many people get spinal cord injuries a year in the United States?

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The American Spinal Injury Association estimates that in 2007, there will be an additional 539 spinal cord injury cases. All severities of the injury resulting in complete functional loss occur in a small percentage of cases in which there is no apparent spinal cord injury in advance. Although a large number of people with minor injuries do not experience the loss of function (severe disability), they may ultimately develop permanent deficits (severe disability). In the remainder of the cases, the cause of the injury appears to be identifiable. All severities of injury, even in those with no identifiable cause, are probably preventable.

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What are common treatments for spinal cord injuries?

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The treatment of spinal cord injuries can be very varied and requires cooperation of all clinicians involved in care of patients with these injuries. Spinal cord injuries are often diagnosed during a period of relative quiescence and are difficult to anticipate until they may develop complications. The treatment of spinal cord injury is often complex and requires careful consideration of the patient's prognosis and individual needs.

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What are the signs of spinal cord injuries?

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The main findings were: (1) The most common signs from SCI are changes to the bladder and bowel function, especially continence problems, especially bladder dysfunction. (2) It may be possible to identify children who might develop a SCI from the absence of these basic physical findings. (3) A specific neurological assessment of children with lower limb SCI can be used more readily by health professionals.

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What is spinal cord injuries?

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SCI is an injury to the spinal cord. There are 5 distinct types of these injuries. They occur following a blunt, penetrating and penetrating/contingent, burns and chemical/mechanical. The injuries occur in the cervical, thoracic and lumbar regions of the spine, with the most common being cervical injuries; followed by thoracic. Most SCI patients will regain control over bodily function and sensation either partially or completely, with a chance of complete loss being uncommon. SCI is a difficult wound with long term consequences. Most disabilities last for life. There are two types of SCI, incomplete and complete.

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Can spinal cord injuries be cured?

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SCI has few absolute cures and the prognosis may be dismal. Nevertheless, with good rehabilitation and adequate care it is possible to improve quality of life.

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What are the latest developments in standing transspinal stimulation followed by robotic gait training for therapeutic use?

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Standing TSS is increasingly used in ambulatory patients with SCI. The use of robotic gait training seems to be worthwhile in order to address several limitations observed in patients who obtain no gait improvement following TSS.

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Is standing transspinal stimulation followed by robotic gait training safe for people?

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A 5 day outpatient programme, which involves a 1-month STS programme in conjunction with 1 month robot-assisted gait training (RAGT) is feasible and safe for people with SCI.

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Does standing transspinal stimulation followed by robotic gait training improve quality of life for those with spinal cord injuries?

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In this pilot study, TSS following RT was not demonstrated to improve patient QoL in individuals with SCI. A multidisciplinary approach, including consideration of patient functioning and QoL may be equally important in this cohort.

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Have there been any new discoveries for treating spinal cord injuries?

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There were several new findings in the treatment of spinal cord injuries. They include a novel design of wheelchair which helps keep patients in an upright position and help them sit up properly; the development of an adjustable compression device for patients with paraplegia and inpatients having had decompressive surgery; and the use of the Bier's maneuver to reduce spine flexion in patients with spinal cord injuries. The authors hope that these will benefit those persons with spinal cord injuries and/or spina bifida. Future research is needed to better understand these benefits as well as the clinical relevance of these findings and future use of them on a continuous basis.

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Has standing transspinal stimulation followed by robotic gait training proven to be more effective than a placebo?

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Standing TSS+RGT provided an initial short term clinical improvement that may help patients with spinal cord injuries achieve a more independent walking performance of a less dependent level. RGT induced over time an improved ambulatory function, which was sustained for at least three months after TSS ended. Recent findings suggest that patients with spinal cord injury may benefit from TSS+RGT.

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