Acute Mechanisms of Cervical Transcutaneous Electrical Stimulation of the Spinal Cord

NCT04843137 | Withdrawn FDA Device

• 1 other identifier: 20.0593
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine how delivery of subthreshold electrical stimulation of the spinal cord alters the excitability of neural pathways and consequently movement performance in healthy and spinal cord injured individuals. Specifically, we assess how stimulation parameters such as electrode configurations and stimulation frequency affect spinal excitability, corticospinal excitability, intracortical excitability, motor unit properties and force production. This study is not an intervention study, but a mechanistic study trying to shed light on how this novel neuromodulatory technique acutely affects the central nervous system.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (4)

• Motor evoked potentials recruitment curves

  Motor evoked potentials are obtained to assess changes in the input/output properties of the corticospinal tract during delivery of tcES. Comparisons are made between no stimulation and stimulation at different frequencies, or with different electrode configurations. This assessment is repeated for different muscles on different days.

  Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)

• Intracortical excitability

  Paired stimulation of the motor cortex is used to assess short interval intracortical inhibition intracortical facilitation during delivery of tcES. Comparisons are made between no stimulation and stimulation at different frequencies, or with different electrode configurations. This assessment is repeated for different muscles on different days.

  Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)

• Intramuscular coherence

  High-density surface electromyography is used to decompose motor units and assess changes in intramuscular coherence during performance of a motor task in the presence of tcES. Comparisons are made between no stimulation and stimulation at different frequencies, or with different electrode configurations. This assessment is repeated for different muscles on different days.

  Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)

• Force control

  Force control during a variety of motor tasks is assessed during delivery of tcES. Comparisons are made between no stimulation and stimulation at different frequencies, or with different electrode configurations within each session. This assessment is repeated for different muscles on different days.

  Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)

Study Arms (1)

Individuals with cervical spinal cord injury

Cohort of individuals who have experiences a chronic spinal cord injury at the cervical level (specifically C5-C7).

Device: Cervical Transcutaneous Electrical Spinal Cord Stimulation

Interventions

Cervical Transcutaneous Electrical Spinal Cord Stimulation DEVICE

Surface electrodes are placed over the cervical spinal cord. Constant current is delivery through these electrodes. Stimulation frequency and electrode configuration are manipulated, and outcome measures are recorded.

Also known as: tcES

Individuals with cervical spinal cord injury

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with chronic, cervical spinal cord injury.

You may qualify if:

• cervical level injury (C5 to C7)
• at least 1 year post-injury

You may not qualify if:

• individuals with damage to the nervous system other than to the spinal cord
• pregnant women (effects of stimulation on the fetus are unknown).
• participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
• participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
• participants with a history of seizures or epilepsy
• participants taking any medication which may reduce seizure threshold

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville, Kentucky Spinal Cord Injury Research Centre

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jessica D'Amico, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 13, 2021
• Study Start: April 6, 2021
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)