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Change in funding, transitioned to new grant and project
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Spinal cord injury leads to long-lasting paralysis and impairment. Re-enabling movement of paralyzed areas is challenging and more information is needed about neurological recovery. The purpose of this study is to understand the contribution of individual neural tracts to movements facilitated by transcutaneous spinal cord stimulation (SCS).
Spinal cord injury leads to long-lasting motor impairment and paralysis that currently is not "curable". Electrical spinal cord stimulation (SCS) is beginning to be used as a neuromodulation technique to re-enable movement of paralyzed areas, however the mechanisms of neurorecovery induced by electrical neuromodulation of the spinal cord remain poorly understood. The goal of this project is to generate evidence-based knowledge of changes in the short-term excitability of corticospinal and reticulospinal neural structures that may mediate immediate improvements in motor function enabled by SCS. The proposed study will: (1) determine which kinds of SCS-facilitated movements are mediated by the corticospinal tract. (2) determine which kinds of SCS-facilitated movements are mediated by the reticulospinal tract. Having a better understanding of the neural mechanisms that are enhanced by SCS can allow the development of therapies that directly target the excitability and plasticity states of these structures towards improved and accelerated recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements | Experimental | This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract first then the arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal track second. |
|
| Reaction time evaluation during non-invasive spinal cord stimulation and leg movements | Experimental | This arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal tract first then the arm will receive the transcranial magnetic stimulation to excite the corticospinal tract second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrophysiology assessment - corticospinal tract | Other | Kinematics and cortical spinal motor excitability |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Corticospinal Tract Excitability After Training | This primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials. Data for this arm were not collected due to early study termination. | 30 minutes before and 30 minutes into intervention |
| Reticulospinal Tract Excitability During Different Types of Movements | This primary outcome measures changes in reticulospinal tract excitability (RST) during training as quantified by changes in reaction time after a startling auditory stimulus. RST contrubution was evaluated for dorsiflexion, plantarflexion, hip flexion movements during precision and range of motion control tasks under three conditions: with transcutaneous spinal cord stimulation or without stimulation. All conditions/evaluations were performed in the same session. 30 repetitions were performed per condition during a single session and averaged for each participant. RST is a ratio calculated by = (visual - startle)/(visual - auditory), where: visual represents the reaction time to a visual cue, auditory represents the reaction time to an auditory cue, startle represents the reaction time to a startling cue. A RST ratio value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task. A value equal or lower than 1 would suggest | During intervention, *1 Day*. |
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Inclusion Criteria:
Healthy volunteers
Exclusion Criteria:
Healthy volunteers
Inclusion criteria:
Participants with spinal cord injury (SCI)
Exclusion criteria:
Participants with spinal cord injury (SCI)
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| Name | Affiliation | Role |
|---|---|---|
| Ismael Seanez, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63105 | United States |
Recruitment was only perform for the second arm of the study: evaluating reticulospinal tract contributions during different types of movements.
Participants performed range-of-motion and precision-control tasks in randomized order during the same session.
As this study was terminated early based on change in funding, no participants were assigned to the "Evaluation of Motor Evoked Potentials" arm, and no data could be provided for this outcome measure.
Participants enrolled from flyers and word of mouth at Washington University in St. Louis. The first participant was enrolled on 06/23/2022, the last participant was enrolled on 03/06/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reaction Time Evaluation During Non-invasive Spinal Cord Stimulation and Leg Movements | This arm will receive a loud auditory stimuli to evaluate the excitability of the reticulospinal tract during non-invasive spinal cord stimulation Electrophysiology assessment - reticulospinal tract contribution during hip range of motion task Electrophysiology assessment - reticulospinal tract contribution during hip precision control task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion precision control task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion precision control task |
| FG001 | Evaluation of Motor Evoked Potentials During Non-invasive Spinal Cord Stimulation and Leg Movements | This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract during non-invasive spinal cord stimulation Electrophysiology assessment - reticulospinal tract contribution during hip range of motion task Electrophysiology assessment - reticulospinal tract contribution during hip precision control task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion precision control task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion precision control task |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This study was terminated early due to change in fundion. Therefore, no participants were enrolled for the evaluation of motor evoked potentials, and no data can be reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | Reaction Time Evaluation During Non-invasive Spinal Cord Stimulation and Leg Movements | This arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal tract first then the arm will receive the transcranial magnetic stimulation to excite the corticospinal tract second Electrophysiology assessment - reticulospinal tract: Kinematics and reticular spinal motor excitability Training with some stimulation: Motor task combined with real or sham stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Corticospinal Tract Excitability After Training | This primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials. Data for this arm were not collected due to early study termination. | Not Posted | 30 minutes before and 30 minutes into intervention | Participants | |||||||||||
| Primary | Reticulospinal Tract Excitability During Different Types of Movements | This primary outcome measures changes in reticulospinal tract excitability (RST) during training as quantified by changes in reaction time after a startling auditory stimulus. RST contrubution was evaluated for dorsiflexion, plantarflexion, hip flexion movements during precision and range of motion control tasks under three conditions: with transcutaneous spinal cord stimulation or without stimulation. All conditions/evaluations were performed in the same session. 30 repetitions were performed per condition during a single session and averaged for each participant. RST is a ratio calculated by = (visual - startle)/(visual - auditory), where: visual represents the reaction time to a visual cue, auditory represents the reaction time to an auditory cue, startle represents the reaction time to a startling cue. A RST ratio value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task. A value equal or lower than 1 would suggest |
Data were collected for single sessions (1 day) for each participant.
Adverse events were monitored during each session.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reaction Time Evaluation During Non-invasive Spinal Cord Stimulation and Leg Movements | This arm will receive a loud auditory stimuli to evaluate the excitability of the reticulospinal tract during non-invasive spinal cord stimulation Electrophysiology assessment - reticulospinal tract contribution during hip range of motion task Electrophysiology assessment - reticulospinal tract contribution during hip precision control task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion precision control task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion precision control task |
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The study was terminated early due to a transition to a new grant with overlapping effort. Therefore, while some data was collected for Aim 2, no data was collected for Aim 1. The statistical analysis was not completed during the duration of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ismael Seáñez | Washington University in St. Louis | 3149357665 | ismaelseanez@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2022 | Nov 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2022 | Nov 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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After baseline evaluations of the effect of transcutaneous SCS on single pulse responses, motor function, and a familiarization phase on a body-machine interface, participants will be randomly assigned to one of two arms in the study.
Arm 1: Participants will receive interventions A and B and transcranial magnetic stimulation is used to evaluate the excitability of the corticospinal tract.
Arm 2: Participants will receive interventions A and B and a loud auditory stimuli is used to evaluate the excitability of the reticulospinal tract.
Arms 1 and 2 will run in parallel. Participants will perform interventions A and B in a randomized cross-over design. In both interventions A and B, participants will use their legs to control a computer cursor as transcutaneous spinal cord stimulation is delivered. Intervention A, participants perform a range-of-motion task, while in intervention B, participants perform a precision-control task.
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| Electrophysiology assessment - reticulospinal tract | Other | Kinematics and reticular spinal motor excitability |
|
| Training with some stimulation | Other | Motor task combined with real or sham stimulation |
|
| BG001 | Evaluation of Motor Evoked Potentials During Non-invasive Spinal Cord Stimulation and Leg Movements | Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract first then the arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal track second. Electrophysiology assessment - corticospinal tract: Kinematics and cortical spinal motor excitability Training with some stimulation: Motor task combined with real or sham stimulation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The average across all participants is reported. |
| Posted |
| Mean |
| Standard Error |
| arbitrary units |
| During intervention, *1 Day*. |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Evaluation of Motor Evoked Potentials During Non-invasive Spinal Cord Stimulation and Leg Movements | This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract during non-invasive spinal cord stimulation Electrophysiology assessment - reticulospinal tract contribution during hip range of motion task Electrophysiology assessment - reticulospinal tract contribution during hip precision control task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during plantarflexion precision control task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion range of motion task Electrophysiology assessment - reticulospinal tract contribution during dorsiflexion precision control task | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014947 | Wounds and Injuries |