Acute Mechanisms of Cervical Transcutaneous Electrical Stimulation of the Spinal Cord

Spinal Cord Injuries Clinical Trial

Official title:

Investigating the Acute Effects of Transcutaneous Electrical Stimulation Parameters on Neural Circuits, Motoneuron Behavior and Motor Performance in Individuals With Cervical Spinal Cord Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04843137
• Other study ID #: 20.0593
• Status: Withdrawn
• Start date: April 6, 2021
• Est. completion date: February 22, 2022

Study information

• Verified date: October 2023
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• individuals with damage to the nervous system other than to the spinal cord
• pregnant women (effects of stimulation on the fetus are unknown).

Transcranial magnetic stimulation-specific exclusion criteria:

• 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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• Cervical Transcutaneous Electrical Spinal Cord Stimulation
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.

Locations

Country	Name	City	State
United States	University of Louisville, Kentucky Spinal Cord Injury Research Centre	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)