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Neural Facilitation of Movements in People With SCI

Primary Purpose

Spinal Cord Injuries

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electrophysiology assessment - corticospinal tract

Electrophysiology assessment - reticulospinal tract

Training with some stimulation

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Healthy volunteers

Age between 16-65
Healthy individuals with no major conditions of any organ system

Exclusion Criteria:

Healthy volunteers

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
History of epilepsy
Implanted metal
Active medical problems

Inclusion criteria:

Participants with spinal cord injury (SCI)

Age between 16-65
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)

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 such as 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 visuo-spatial 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 University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements

Reaction time evaluation during non-invasive spinal cord stimulation and leg movements

Arm Description

This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract first then the arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal track second.

This arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal tract first then the arm will receive the transcranial magnetic stimulation to excite the corticospinal tract second

Outcomes

Primary Outcome Measures

Changes in corticospinal tract excitability after training

This primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials.

Changes in reticulospinal tract excitability after training

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05354206

First Posted

April 25, 2022

Last Updated

June 8, 2023

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05354206

Brief Title

Neural Facilitation of Movements in People With SCI

Official Title

Neural Facilitation of Stimulation-assisted Movements in People With Spinal Cord Injury

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Terminated

Why Stopped

Change in funding, transitioned to new grant and project

Study Start Date

July 12, 2022 (Actual)

Primary Completion Date

March 6, 2023 (Actual)

Study Completion Date

March 6, 2023 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Spinal cord injury leads to long-lasting paralysis and impairment. Re-enabling movement of paralyzed areas is challenging and more information is needed about neurological recovery. The purpose of this study is to understand the contribution of individual neural tracts to movements facilitated by transcutaneous spinal cord stimulation (SCS).

Detailed Description

Spinal cord injury leads to long-lasting motor impairment and paralysis that currently is not "curable". Electrical spinal cord stimulation (SCS) is beginning to be used as a neuromodulation technique to re-enable movement of paralyzed areas, however the mechanisms of neurorecovery induced by electrical neuromodulation of the spinal cord remain poorly understood. The goal of this project is to generate evidence-based knowledge of changes in the short-term excitability of corticospinal and reticulospinal neural structures that may mediate immediate improvements in motor function enabled by SCS. The proposed study will: (1) determine which kinds of SCS-facilitated movements are mediated by the corticospinal tract. (2) determine which kinds of SCS-facilitated movements are mediated by the reticulospinal tract. 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, neuromodulation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

After baseline evaluations of the effect of transcutaneous SCS on single pulse responses, motor function, and a familiarization phase on a body-machine interface, participants will be randomly assigned to one of two arms in the study. Arm 1: Participants will receive intervention A during the initial phase of the study and intervention B during the second phase of the study. Arm 2: Participants will receive intervention B during the initial phase of the study and intervention A during the second phase of the study. In both interventions A and B, participants will use their legs to control a computer cursor as transcutaneous spinal cord stimulation is delivered. In intervention A, the investigators will use transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract during the movement tasks. In intervention B, the investigators will use loud auditory stimuli to evaluate the excitability of the reticulospinal tract during the movement tasks.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements

Arm Type

Experimental

Arm Description

Arm Title

Reaction time evaluation during non-invasive spinal cord stimulation and leg movements

Arm Type

Experimental

Arm Description

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)

Training with some stimulation

Intervention Description

Motor task combined with real or sham stimulation

Primary Outcome Measure Information:

Title

Changes in corticospinal tract excitability after training

Description

This primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials.

Time Frame

30 minutes before and 30 minutes into intervention

Title

Changes in reticulospinal tract excitability after training

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 into intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteers Age between 16-65 Healthy individuals with no major conditions of any organ system Exclusion Criteria: Healthy volunteers 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 History of epilepsy Implanted metal Active medical problems Inclusion criteria: Participants with spinal cord injury (SCI) Age between 16-65 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) 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 such as 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 visuo-spatial 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

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

12. IPD Sharing Statement

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Neural Facilitation of Movements in People With SCI

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