Spinal Cord InjuriesNCT05354206
Neural Facilitation of Movements in People With SCI
A study testing Electrophysiology assessment - corticospinal tract, Electrophysiology assessment - reticulospinal tract and Training with some stimulation in people with Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Electrophysiology assessment - corticospinal tract, Electrophysiology assessment - reticulospinal tract and Training with some stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 6 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age between 16-65
- Healthy individuals with no major conditions of any organ system
- Participants with spinal cord injury (SCI)
- Age between 16-65
- Traumatic SCI C4-T9 level, complete (ASIA A) or incomplete (ASIA B, C or D)
Show all 11Show fewer
- at least 1 year post injury
- Stable medical condition
- difficulty independently performing leg movements in routine activities
- able to follow simple commands
- able to speak and respond to questions
Who cannot join
- Healthy volunteers
- Not willing or able to provide consent
- Any acute or chronic pain condition
- Any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study appointment
- Use of caffeine with 3 hours of study appointment
Show all 34Show fewer
- History of epilepsy
- Implanted metal
- Active medical problems
- Participants with spinal cord injury (SCI)
- Not willing or able to provide consent
- Any acute or chronic pain condition
- Any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study appointment
- Use of caffeine with 3 hours of study appointment
- Presence of tremors, spasms and other significant involuntary movements
- Etiology of SCI other than trauma
- Concomitant neurologic disease such as traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy)
- History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc).
- Severe joint contractures disabling or restricting lower limb movements.
- Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities
- Depression, anxiety, or cognitive impairment
- Deficit of visuo-spatial orientation
- Sitting tolerance less than 1 hour
- Severe hearing or visual deficiency
- Miss more than 3 appointments without notification
- Unable to comply with any of the procedures in the protocol
- Botulinum toxin injection in lower extremity muscles in the prior six months
- Any passive implants (osteosynthesis material, metallic plates or screws) below T9.
- Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.)
- History of alcoholism or another drug abuse
- Pregnancy (or possible pregnancy)
- Having an Intrathecal Baclofen Therapy Pump (ITB pump)
- History of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Facilitation of Stimulation-assisted Movements in People With Spinal Cord Injury
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).
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Electrophysiology assessment - corticospinal tract, Electrophysiology assessment - reticulospinal tract, Training with some stimulation
- Keywords
- spinal cord injury, spinal cord stimulation, rehabilitation, neuromodulation
- 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.
Electrophysiology assessment - corticospinal tractOther
Kinematics and cortical spinal motor excitability
Electrophysiology assessment - reticulospinal tractOther
Kinematics and reticular spinal motor excitability
Training with some stimulationOther
Motor task combined with real or sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electrophysiology assessment - corticospinal tract; Other: Training with some stimulation |
| 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 Receives: Other: Electrophysiology assessment - reticulospinal tract; Other: Training with some stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: During intervention, *1 Day*.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start23 Jun 2022
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Why it stopped: Change in funding, transitioned to new grant and project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismael Seáñez, Washington University School of Medicine
- Investigators
- Ismael Seanez, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354206
- Sponsor's protocol ID
- 202111151
- Status last verified
- Oct 2024
- First submitted
- 25 Apr 2022
- Last updated
- 22 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Facilitation of Stimulation-assisted Movements in People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05354206
- Acronym / sponsor ID
- 202111151
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, spinal cord stimulation, rehabilitation, neuromodulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in funding, transitioned to new grant and project
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Posted 22 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements | Experimental | Other: Electrophysiology assessment - corticospinal tract, Other: Training with some stimulationThis 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 | Other: Electrophysiology assessment - reticulospinal tract, Other: Training with some stimulationThis 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 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy volunteers
- Age between 16-65
- Healthy individuals with no major conditions of any organ system
- Participants with spinal cord injury (SCI)
- Age between 16-65
Key exclusion criteria (34 listed)
- Healthy volunteers
- Not willing or able to provide consent
- Any acute or chronic pain condition
- Any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study appointment
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 |
|---|---|---|
| Electrophysiology assessment - corticospinal tractKinematics and cortical spinal motor excitability | Other | Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements |
| Electrophysiology assessment - reticulospinal tractKinematics and reticular spinal motor excitability | Other | Reaction time evaluation during non-invasive spinal cord stimulation and leg movements |
| Training with some stimulationMotor task combined with real or sham stimulation | Other | Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements, Reaction time evaluation during non-invasive spinal cord stimulation and leg movements |
Primary outcome
Changes in Corticospinal Tract Excitability After Training
Time frame: 30 minutes before and 30 minutes into intervention
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.
Reticulospinal Tract Excitability During Different Types of Movements
Time frame: During intervention, *1 Day*.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ismael Seanez, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiology assessment - corticospinal tract, Electrophysiology assessment - reticulospinal tract and Training with some stimulation in people with Spinal Cord Injuries, run by Washington University School of Medicine 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 11 inclusion and 34 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: stopped early, as of the sponsor's last update on 22 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Corticospinal Tract Excitability After Training (time frame: 30 minutes before and 30 minutes into intervention). The study lists 2 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 22 Nov 2024.