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Spinal Cord Stimulation and Training

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrophysiology assessment - corticospinal tract
Electrophysiology assessment - reticulospinal tract
Electrophysiology assessment - spinal motoneuron
Activity-based training
Transcutaneous spinal cord stimulation
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injuries focused on measuring spinal cord injury, spinal cord stimulation, rehabilitation

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy Volunteers

  • Age between 16 and 65 years old
  • Healthy people with no major comorbidities of any organ system

Exclusion Criteria:

Healthy Volunteers

  • Subjects younger than 16 or older than 65 years old
  • Subjects not providing consent or not able to consent
  • Subjects with any acute or chronic pain condition
  • Subjects with any acute or chronic disease of a major organ system
  • Use of analgesics within 24 hours prior to study period
  • Use of caffeine with 3 hours of study appointment

Inclusion criteria:

Participants with spinal cord injury (SCI)

  • Age between 16-65 years old
  • Traumatic SCI C4-T9 level, complete (ASIA A) or incomplete (ASIA B, C or D)
  • at least 1 year post injury
  • Stable medical condition
  • difficulty independently performing leg movements in routine activities
  • able to follow simple commands
  • able to speak and respond to questions

Exclusion criteria:

Participants with spinal cord injury (SCI)

  • Subjects younger than 16 or older than 65 years old
  • Not willing or able to provide consent
  • Any acute or chronic pain condition
  • Any acute or chronic disease of a major organ system
  • Use of analgesics within 24 hours prior to study appointment
  • Use of caffeine with 3 hours of study appointment
  • Presence of tremors, spasms and other significant involuntary movements
  • Etiology of SCI other than trauma
  • Concomitant neurologic disease traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy)
  • History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc).
  • Severe joint contractures disabling or restricting lower limb movements.
  • Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities
  • Depression, anxiety, or cognitive impairment
  • Deficit of visuospatial orientation
  • Sitting tolerance less than 1 hour
  • Severe hearing or visual deficiency
  • Miss more than 3 appointments without notification
  • Unable to comply with any of the procedures in the protocol
  • Botulinum toxin injection in lower extremity muscles in the prior six months
  • Any passive implants (osteosynthesis material, metallic plates or screws) below T9.
  • Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.)
  • History of alcoholism or another drug abuse
  • Pregnancy (or possible pregnancy)
  • Having an Intrathecal Baclofen Therapy Pump (ITB pump)
  • History of epilepsy

Sites / Locations

  • Washington UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Experimental: Non-invasive spinal cord stimulation

Experimental: Activity-based training

Experimental: Activity-based training wtih non-invasive spinal cord stimulation

Experimental: Non-invasive spinal cord stimulation and strength training

Experimental: Non-invasive spinal cord stimulation and precision training

Experimental: Long-term activity-based training with non-invasive spinal cord stimulation

Arm Description

This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.

This arm will perform 30 minutes of activity-based training using leg movements.

This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.

This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.

This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.

This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation

Outcomes

Primary Outcome Measures

Motor evoked potentials amplitude and latency
This primary outcome is a measure of changes in corticospinal tract excitability and plasticity as quantified by changes in the amplitude size and onset latency of motor evoked potentials elicited via transcranial magnetic stimulation.
Reaction time to startle response
This primary outcome is a measure of changes in reticulospinal tract excitability after training as quantified by changes in reaction time after a startling auditory stimulus.
F-wave response persistence
This primary outcome is a measure of changes in spinal motoneuron excitability as quantified by changes in the persistence of F-wave responses elicited via peripheral nerve stimulation.

Secondary Outcome Measures

Changes in time to completion from baseline
Participants will perform cursor control as a computer game. This outcome measure is the time it takes participants to complete each task.
Change in movement smoothness
This outcome is a measure of changes in movement smoothness when operating the computer cursor with the body.

Full Information

First Posted
July 8, 2022
Last Updated
August 10, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05472584
Brief Title
Spinal Cord Stimulation and Training
Official Title
Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will help the investigators better understand the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal and spinal neural circuits and how the changes impact the improvements of spinal cord stimulation (SCS) mediated motor function.
Detailed Description
The goal of this project is to determine the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal, and spinal neural circuits that are involved in SCS-mediated motor function improvements in individuals with spinal cord injury (SCI). The study will: (1) Determine the short-term effects in neural excitability induced by SCS and activity-based training. (2) Determine the effect of motor training on short-term changes in neural excitability enabled by SCS. (3) Determine the long-term changes in motor control and neural plasticity induced by combined SCS and activity-based training in individuals with chronic SCI. Having a better understanding of the neural mechanisms that are enhanced by SCS can allow the development of therapies that directly target the excitability and plasticity states of these structures towards improved and accelerated recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, spinal cord stimulation, rehabilitation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Non-invasive spinal cord stimulation
Arm Type
Experimental
Arm Description
This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
Arm Title
Experimental: Activity-based training
Arm Type
Experimental
Arm Description
This arm will perform 30 minutes of activity-based training using leg movements.
Arm Title
Experimental: Activity-based training wtih non-invasive spinal cord stimulation
Arm Type
Experimental
Arm Description
This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
Arm Title
Experimental: Non-invasive spinal cord stimulation and strength training
Arm Type
Experimental
Arm Description
This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Arm Title
Experimental: Non-invasive spinal cord stimulation and precision training
Arm Type
Experimental
Arm Description
This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
Arm Title
Experimental: Long-term activity-based training with non-invasive spinal cord stimulation
Arm Type
Experimental
Arm Description
This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation
Intervention Type
Other
Intervention Name(s)
Electrophysiology assessment - corticospinal tract
Intervention Description
Kinematics and cortical spinal motor excitability
Intervention Type
Other
Intervention Name(s)
Electrophysiology assessment - reticulospinal tract
Intervention Description
Kinematics and reticular spinal motor excitability
Intervention Type
Other
Intervention Name(s)
Electrophysiology assessment - spinal motoneuron
Intervention Description
Kinematics and spinal motoneuron excitability
Intervention Type
Other
Intervention Name(s)
Activity-based training
Intervention Description
Motor task
Intervention Type
Other
Intervention Name(s)
Transcutaneous spinal cord stimulation
Intervention Description
Non-invasive spinal cord stimulation
Primary Outcome Measure Information:
Title
Motor evoked potentials amplitude and latency
Description
This primary outcome is a measure of changes in corticospinal tract excitability and plasticity as quantified by changes in the amplitude size and onset latency of motor evoked potentials elicited via transcranial magnetic stimulation.
Time Frame
30 minutes before and 30 minutes after intervention; 4 weeks
Title
Reaction time to startle response
Description
This primary outcome is a measure of changes in reticulospinal tract excitability after training as quantified by changes in reaction time after a startling auditory stimulus.
Time Frame
30 minutes before and 30 minutes after intervention; 4 weeks
Title
F-wave response persistence
Description
This primary outcome is a measure of changes in spinal motoneuron excitability as quantified by changes in the persistence of F-wave responses elicited via peripheral nerve stimulation.
Time Frame
30 minutes before and 30 minutes after intervention; 4 weeks
Secondary Outcome Measure Information:
Title
Changes in time to completion from baseline
Description
Participants will perform cursor control as a computer game. This outcome measure is the time it takes participants to complete each task.
Time Frame
Baseline, 30 minutes, and 4 weeks
Title
Change in movement smoothness
Description
This outcome is a measure of changes in movement smoothness when operating the computer cursor with the body.
Time Frame
Baseline, 30 minutes, and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Volunteers Age between 16 and 65 years old Healthy people with no major comorbidities of any organ system Exclusion Criteria: Healthy Volunteers Subjects younger than 16 or older than 65 years old Subjects not providing consent or not able to consent Subjects with any acute or chronic pain condition Subjects with any acute or chronic disease of a major organ system Use of analgesics within 24 hours prior to study period Use of caffeine with 3 hours of study appointment Inclusion criteria: Participants with spinal cord injury (SCI) Age between 16-65 years old Traumatic SCI C4-T9 level, incomplete (ASIA C or D) at least 1 year post injury Stable medical condition difficulty independently performing leg movements in routine activities able to follow simple commands able to speak and respond to questions Exclusion criteria: Participants with spinal cord injury (SCI) Subjects younger than 16 or older than 65 years old Not willing or able to provide consent Any acute or chronic pain condition Any acute or chronic disease of a major organ system Use of analgesics within 24 hours prior to study appointment Use of caffeine with 3 hours of study appointment Presence of tremors, spasms and other significant involuntary movements Etiology of SCI other than trauma Concomitant neurologic disease traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy) History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc). Severe joint contractures disabling or restricting lower limb movements. Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities Depression, anxiety, or cognitive impairment Deficit of visuospatial orientation Sitting tolerance less than 1 hour Severe hearing or visual deficiency Miss more than 3 appointments without notification Unable to comply with any of the procedures in the protocol Botulinum toxin injection in lower extremity muscles in the prior six months Any passive implants (osteosynthesis material, metallic plates or screws) below T9. Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.) History of alcoholism or another drug abuse Pregnancy (or possible pregnancy) Having an Intrathecal Baclofen Therapy Pump (ITB pump) History of epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Walker, OTD
Phone
314-273-7010
Email
walker.k@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ismael Seanez, PhD
Phone
314-935-7665
Email
ismaelseanez@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismael Seanez, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Walker, OTD
Phone
314-273-7010
Email
walker.k@wustl.edu
First Name & Middle Initial & Last Name & Degree
Ismael Seanez, PhD
Phone
314-935-7665
Email
ismaelseanez@wustl.edu

12. IPD Sharing Statement

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Spinal Cord Stimulation and Training

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