Spinal Cord Stimulation and Training

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05472584

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Other: Electrophysiology assessment - corticospinal tract Other: Electrophysiology assessment - reticulospinal tract Other: Electrophysiology assessment - spinal motoneuron Other: Activity-based training Other: Transcutaneous spinal cord stimulation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Non-invasive spinal cord stimulation This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.	Other: Electrophysiology assessment - corticospinal tract Kinematics and cortical spinal motor excitability Other: Electrophysiology assessment - reticulospinal tract Kinematics and reticular spinal motor excitability Other: Electrophysiology assessment - spinal motoneuron Kinematics and spinal motoneuron excitability Other: Transcutaneous spinal cord stimulation Non-invasive spinal cord stimulation
Experimental: Experimental: Activity-based training This arm will perform 30 minutes of activity-based training using leg movements.	Other: Electrophysiology assessment - corticospinal tract Kinematics and cortical spinal motor excitability Other: Electrophysiology assessment - reticulospinal tract Kinematics and reticular spinal motor excitability Other: Electrophysiology assessment - spinal motoneuron Kinematics and spinal motoneuron excitability Other: Activity-based training Motor task
Experimental: Experimental: Activity-based training wtih non-invasive spinal cord stimulation This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.	Other: Electrophysiology assessment - corticospinal tract Kinematics and cortical spinal motor excitability Other: Electrophysiology assessment - reticulospinal tract Kinematics and reticular spinal motor excitability Other: Electrophysiology assessment - spinal motoneuron Kinematics and spinal motoneuron excitability Other: Activity-based training Motor task Other: Transcutaneous spinal cord stimulation Non-invasive spinal cord stimulation
Experimental: Experimental: Non-invasive spinal cord stimulation and strength training This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.	Other: Electrophysiology assessment - corticospinal tract Kinematics and cortical spinal motor excitability Other: Electrophysiology assessment - reticulospinal tract Kinematics and reticular spinal motor excitability Other: Electrophysiology assessment - spinal motoneuron Kinematics and spinal motoneuron excitability Other: Activity-based training Motor task Other: Transcutaneous spinal cord stimulation Non-invasive spinal cord stimulation
Experimental: Experimental: Non-invasive spinal cord stimulation and precision training This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.	Other: Electrophysiology assessment - corticospinal tract Kinematics and cortical spinal motor excitability Other: Electrophysiology assessment - reticulospinal tract Kinematics and reticular spinal motor excitability Other: Electrophysiology assessment - spinal motoneuron Kinematics and spinal motoneuron excitability Other: Activity-based training Motor task Other: Transcutaneous spinal cord stimulation Non-invasive spinal cord stimulation
Experimental: Experimental: Long-term activity-based training with non-invasive spinal cord stimulation This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation	Other: Electrophysiology assessment - corticospinal tract Kinematics and cortical spinal motor excitability Other: Electrophysiology assessment - reticulospinal tract Kinematics and reticular spinal motor excitability Other: Electrophysiology assessment - spinal motoneuron Kinematics and spinal motoneuron excitability Other: Activity-based training Motor task Other: Transcutaneous spinal cord stimulation Non-invasive spinal cord stimulation

Outcome Measures

Primary Outcome Measures

Motor evoked potentials amplitude and latency [30 minutes before and 30 minutes after intervention; 4 weeks]
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 [30 minutes before and 30 minutes after intervention; 4 weeks]
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 [30 minutes before and 30 minutes after intervention; 4 weeks]
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 [Baseline, 30 minutes, and 4 weeks]
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 [Baseline, 30 minutes, and 4 weeks]
This outcome is a measure of changes in movement smoothness when operating the computer cursor with the body.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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), 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University	Saint Louis	Missouri	United States	63105

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Ismael Seanez, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ismael Seáñez, Assistant Professor of Biomedical Engineering and Neurosurgery, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT05472584

Other Study ID Numbers:

202206159

First Posted:

Jul 25, 2022

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ismael Seáñez, Assistant Professor of Biomedical Engineering and Neurosurgery, Washington University School of Medicine

spinal cord injury, spinal cord stimulation, rehabilitation

Additional relevant MeSH terms:

Spinal Cord Injuries

Study Results

No Results Posted as of Jul 25, 2022