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Activity-Dependent Transspinal Stimulation in SCI

Primary Purpose

Spinal Cord Injuries, Paraplegia, Spinal, Tetraplegia/Tetraparesis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic gait training
Robotic gait training and low-frequency transspinal stimulation
Robotic gait training and high-frequency transspinal stimulation
Sponsored by
City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring locomotor training, transcutaneous spinal cord stimulation, Lokomat, brain stimulation, peripheral nerve stimulation, H-reflex, spinal neural circuits, neuroplasticity, recovery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Clinical diagnosis of motor incomplete spinal cord injury (SCI).
  • SCI is above thoracic 12 vertebra.
  • Absent permanent ankle joint contractures.
  • SCI occurred 6 months before enrollment to the study.

Exclusion criteria:

  • Supraspinal lesions
  • Neuropathies of the peripheral nervous system
  • Degenerative neurological disorders of the spine or spinal cord
  • Motor complete SCI
  • Presence of pressure sores
  • Urinary tract infection
  • Neoplastic or vascular disorders of the spine or spinal cord
  • Pregnant women or women who suspect they may be or may become pregnant.
  • People with cochlear implants, pacemaker and implanted stimulators
  • People with history of seizures
  • People with implanted Baclofen pumb

Sites / Locations

  • Veterans Affairs Medical Center
  • Department of Physical Therapy, Motor Control and NeuroRecovery Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Robotic gait training

Robotic gait training & low-frequeny transspinal stimulation.

Robotic gait training & high-frequeny transspinal stimulation.

Arm Description

Robotic gait training only

Robotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at low frequency (0.3 Hz).

Robotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at high frequency (30 Hz).

Outcomes

Primary Outcome Measures

Plasticity of cortical and corticospinal neuronal circuits
Neurophysiological tests probing cortical and corticospinal excitability will be measured before and after the intervention. Single-pulse transcranial magnetic stimulation (TMS) will be used to assemble the recruitment curve of motor evoked potentials, and paired-pulse TMS will be used to probe changes in cortical inhibitory and facilitatory neuronal circuits.
Plasticity of spinal neuronal circuits
Neurophysiological tests probing spinal reflex excitability will be measured before and after each intervention by posterior tibial and sural nerves stimulation during Lokomat-assisted stepping depicting the amplitude modulation of the soleus H-reflex and tibialis anterior flexor reflex.

Secondary Outcome Measures

Senorimotor leg motor function
Manual muscle test and leg sensation based on American Spinal Injury Association guidelines.
Spasticity
Tardieu scale
Walking function
Two-minute walk test and 10 meter timed test.

Full Information

First Posted
September 11, 2018
Last Updated
August 8, 2022
Sponsor
City University of New York
Collaborators
Bronx Veterans Medical Research Foundation, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03669302
Brief Title
Activity-Dependent Transspinal Stimulation in SCI
Official Title
Activity-Dependent Transspinal Stimulation for Recovery of Walking Ability After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
City University of New York
Collaborators
Bronx Veterans Medical Research Foundation, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Robotic gait training is often used with the aim to improve walking ability in individuals with Spinal Cord Injury. However, robotic gait training alone may not be sufficient. This study will compare the effects of robotic gait training alone to robotic gait training combined with either low-frequency or high-frequency non-invasive transspinal electrical stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of nerve function will be performed before and after 20 sessions of gait training with or without stimulation.
Detailed Description
People with spinal cord injury (SCI) have motor dysfunction that results in substantial social, personal, and economic costs. Robotic gait training is often used with the aim to improve walking ability in these individuals. Investigators recently reported that robotic gait training reorganizes spinal neuronal circuits, improves motor activity, and contributes substantially to recovery of walking ability in people with motor incomplete SCI. However, pathological muscle tone and abnormal muscle activation patterns during assisted stepping were still evident after multiple sessions of robotic gait training. Locomotor training alone may thus be insufficient to strengthen weak neuronal synapses connecting the brain with the spinal cord or to fully optimize spinal neural circuits. On the other hand, spinal cord stimulation increases sprouting and plasticity of axons and dendrites in spinalized animals. Furthermore, transcutaneous spinal cord stimulation (termed here transspinal stimulation) in people with SCI can evoke rhythmic leg muscle activity when gravity is eliminated. A fundamental knowledge gap still exists on induction of functional neuroplasticity and recovery of leg motor function after repetitive thoracolumbar transspinal stimulation during body weight supported (BWS) assisted stepping in people with SCI. The central working hypothesis in this study is that transspinal stimulation delivered during BWS-assisted stepping provides a tonic excitatory input increasing the overall responsiveness of the spinal cord and improving motor output. The investigators will address 3 specific aims: Establish induction of neuroplasticity and improvements in leg sensorimotor function in people with motor incomplete SCI when transspinal stimulation is delivered during BWS-assisted stepping at low frequencies (0.3 Hz; Specific Aim 1) and at high frequencies (30 Hz; Specific Aim 2), and when BWS-assisted step training is administered without transspinal stimulation (Specific Aim 3). In all groups, outcomes after 20 sessions will be measured via state-of-the-art neurophysiological methods. Corticospinal circuit excitability will be measured via transcranial magnetic stimulation motor evoked potentials in seated subjects (Aims 1A, 2A, 3A). Soleus H-reflex and tibialis anterior flexor reflex excitability patterns will be measured during assisted stepping (Aims 1B, 2B, 3B). Sensorimotor function will be evaluated via standardized clinical tests of gait and strength (Aims 1C, 2C, 3C). Additionally, poly-electromyographic analysis of coordinated muscle activation will be measured in detail. It is hypothesized that transspinal stimulation at 30 Hz during assisted stepping improves leg motor function and decreases ankle spasticity more compared to 0.3 Hz. It is further hypothesized that transspinal stimulation at 30 Hz normalizes the abnormal phase-dependent soleus H-reflex and flexor reflex modulation commonly observed during stepping in people with motor incomplete SCI. To test the project hypotheses, 45 people with motor incomplete SCI will be randomly assigned to receive 20 sessions of transspinal stimulation at 0.3 or 30 Hz during BWS-assisted stepping or 20 sessions of BWS-assisted stepping without transspinal stimulation (15 subjects per group). Results from this research project will advance considerably the field of spinal cord research and change the standard of care because there is great potential for development of novel and effective rehabilitation strategies to improve leg motor function after motor incomplete SCI in humans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Paraplegia, Spinal, Tetraplegia/Tetraparesis, Paraplegia, Spastic
Keywords
locomotor training, transcutaneous spinal cord stimulation, Lokomat, brain stimulation, peripheral nerve stimulation, H-reflex, spinal neural circuits, neuroplasticity, recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals with Spinal Cord Imjury will be randomly assigned to receive robotic gait training with the Lokomat, and/or Lokomat gait training combined with non-invasive thoracolumbar transspinal stimulation at 0.3 or at 30 Hz.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic gait training
Arm Type
Sham Comparator
Arm Description
Robotic gait training only
Arm Title
Robotic gait training & low-frequeny transspinal stimulation.
Arm Type
Experimental
Arm Description
Robotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at low frequency (0.3 Hz).
Arm Title
Robotic gait training & high-frequeny transspinal stimulation.
Arm Type
Experimental
Arm Description
Robotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at high frequency (30 Hz).
Intervention Type
Other
Intervention Name(s)
Robotic gait training
Intervention Description
Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
Intervention Type
Device
Intervention Name(s)
Robotic gait training and low-frequency transspinal stimulation
Intervention Description
Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a single pulse at 0.3 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
Intervention Type
Device
Intervention Name(s)
Robotic gait training and high-frequency transspinal stimulation
Intervention Description
Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
Primary Outcome Measure Information:
Title
Plasticity of cortical and corticospinal neuronal circuits
Description
Neurophysiological tests probing cortical and corticospinal excitability will be measured before and after the intervention. Single-pulse transcranial magnetic stimulation (TMS) will be used to assemble the recruitment curve of motor evoked potentials, and paired-pulse TMS will be used to probe changes in cortical inhibitory and facilitatory neuronal circuits.
Time Frame
3 years
Title
Plasticity of spinal neuronal circuits
Description
Neurophysiological tests probing spinal reflex excitability will be measured before and after each intervention by posterior tibial and sural nerves stimulation during Lokomat-assisted stepping depicting the amplitude modulation of the soleus H-reflex and tibialis anterior flexor reflex.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Senorimotor leg motor function
Description
Manual muscle test and leg sensation based on American Spinal Injury Association guidelines.
Time Frame
3 years
Title
Spasticity
Description
Tardieu scale
Time Frame
3 years
Title
Walking function
Description
Two-minute walk test and 10 meter timed test.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Clinical diagnosis of motor incomplete spinal cord injury (SCI). SCI is above thoracic 12 vertebra. Absent permanent ankle joint contractures. SCI occurred 6 months before enrollment to the study. Exclusion criteria: Supraspinal lesions Neuropathies of the peripheral nervous system Degenerative neurological disorders of the spine or spinal cord Motor complete SCI Presence of pressure sores Urinary tract infection Neoplastic or vascular disorders of the spine or spinal cord Pregnant women or women who suspect they may be or may become pregnant. People with cochlear implants, pacemaker and implanted stimulators People with history of seizures People with implanted Baclofen pumb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Knikou, PT, PhD
Organizational Affiliation
Research Foundation of the City University of New York
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noam Y Harel, MD, PhD
Organizational Affiliation
VA Office of Research and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Department of Physical Therapy, Motor Control and NeuroRecovery Laboratory
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States

12. IPD Sharing Statement

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Citation
Wirz M, Zemon DH, Rupp R, Scheel A, Colombo G, Dietz V, Hornby TG. Effectiveness of automated locomotor training in patients with chronic incomplete spinal cord injury: a multicenter trial. Arch Phys Med Rehabil. 2005 Apr;86(4):672-80. doi: 10.1016/j.apmr.2004.08.004.
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Activity-Dependent Transspinal Stimulation in SCI

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