Acute Mechanisms of Cervical Transcutaneous Electrical Stimulation of the Spinal Cord

NCT ID: NCT04843137

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-06

Study Completion Date

2022-02-22

Brief Summary

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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

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Conditions

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Spinal Cord Injuries

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals with cervical spinal cord injury

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

Cervical Transcutaneous Electrical Spinal Cord Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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tcES

Eligibility Criteria

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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).


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica D'Amico, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville, Kentucky Spinal Cord Injury Research Centre

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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20.0593

Identifier Type: -

Identifier Source: org_study_id

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