Acute Mechanisms of Cervical Transcutaneous Electrical Stimulation of the Spinal Cord

Withdrawn

• Conditions: Spinal Cord Injuries
• Interventions: Device: Cervical Transcutaneous Electrical Spinal Cord Stimulation

• Registration Number: NCT04843137
• Lead Sponsor: University of Louisville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-06
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-13
• Primary Completion: 2022-02-22
• Study Completion: 2022-02-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with cervical spinal cord injury	Cervical Transcutaneous Electrical Spinal Cord Stimulation	Cohort of individuals who have experiences a chronic spinal cord injury at the cervical level (specifically C5-C7).

Primary Outcome Measures

Name	Time	Method
Force control	Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)	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.
Motor evoked potentials recruitment curves	Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)	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.
Intracortical excitability	Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)	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.
Intramuscular coherence	Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)	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.

Trial Locations

Locations (1)

University of Louisville, Kentucky Spinal Cord Injury Research Centre; 🇺🇸 Louisville, Kentucky, United States