Spinal Cord InjuriesNCT04843137
Acute Mechanisms of Cervical Transcutaneous Electrical Stimulation of the Spinal Cord
An observational study of Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Cervical Transcutaneous Electrical Spinal Cord Stimulation
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2021to 22 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with chronic, cervical spinal cord injury.
Who may be able to join
- cervical level injury (C5 to C7)
- at least 1 year post-injury
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville, Kentucky Spinal Cord Injury Research Centre
Louisville, Kentucky, 40202
About this study
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
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
- Being tested
- Cervical Transcutaneous Electrical Spinal Cord Stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Transcutaneous Electrical Spinal Cord StimulationDevice
Also called tcES
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with cervical spinal cord injury | Cohort of individuals who have experiences a chronic spinal cord injury at the cervical level (specifically C5-C7). Receives: Device: Cervical Transcutaneous Electrical Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start6 Apr 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Why it stopped: Closed study at UofL, may reopen at new institution in the future. No participants have enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica D'Amico, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843137
- Sponsor's protocol ID
- 20.0593
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2021
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04843137
- Acronym / sponsor ID
- 20.0593
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Closed study at UofL, may reopen at new institution in the future. No participants have enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with cervical spinal cord injury | – | Device: Cervical Transcutaneous Electrical Spinal Cord StimulationCohort of individuals who have experiences a chronic spinal cord injury at the cervical level (specifically C5-C7). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with chronic, cervical spinal cord injury.
Key inclusion criteria (2 listed)
- cervical level injury (C5 to C7)
- at least 1 year post-injury
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Transcutaneous Electrical Spinal Cord StimulationAlso: tcESSurface 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. | Device | Individuals with cervical spinal cord injury |
Primary outcome
Motor evoked potentials recruitment curves
Time frame: 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
Time frame: 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
Time frame: 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.
Force control
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica D'Amico, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor evoked potentials recruitment curves (time frame: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.