Spinal Cord InjuriesNCT04286191
Physiological Changes Induced Through MEP Conditioning in People With SCI
A study testing Operant Conditioning in people with Spinal Cord Injuries and Neurological Injury, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The study team is currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neurological Injury, Paralysis
- What is being tested?
- Operant Conditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 30 Nov 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neurologically stable (>1 year post SCI)
- Medical clearance to participate
- Ability to ambulate at least 10 m with or without an assistive device (except for parallel bars)
- Signs of weak ankle dorsiflexion at least unilaterally
- Expectation that current medication will be maintained without change for at least 3 months; stable use of anti-spasticity medication is accepted
Who cannot join
- motoneuron injury
- known cardiac condition (e.g., history of myocardial infarction, congestive heart failure, pacemaker use)
- medically unstable condition
- cognitive impairment
- history of epileptic seizures
- metal implants in the cranium
Show all 11Show fewer
- implanted biomedical device in or above the ches (e.g., a cardiac pacemaker, cochlear implant)
- no measurable MEP elicited
- unable to produce any voluntary TA EMG activity
- extensive use of functional electrical stimulation to the leg on a daily basis
- pregnancy (due to changes in weight and posture and potential medical instability)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Characterization of Physiological Changes Induced Through Motor-evoked Potential Conditioning in People With Spinal Cord Injury
The study team is currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. After spinal cord injury, brain-to-muscle connections are often interrupted. Because these connections are important in movement control, when they are not working well, movements may be disturbed. Researchers have found that people can learn to strengthen these connections through training. Strengthening these connections may be able to improve movement control and recovery after injuries.
Research participants will be asked to stand, sit, and walk during the study sessions. Electrodes are placed on the skin over leg muscles for monitoring muscle activity. For examining brain-to-muscle connections, the study team will use transcranial magnetic stimulation. The stimulation is applied over the head and will indirectly stimulate brain cells with little or no discomfort.
Participation in this study requires approximately three sessions per week for four months, followed by two to three sessions over another three months. Each session lasts approximately 1 hour.
- Being tested
- Operant Conditioning, Control Group
- Keywords
- Corticospinal Tract, Neuroplasticity
- Medical subject headings
- Spinal Cord Injuries, Trauma, Nervous System, Paralysis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operant ConditioningCombination product
This is a training intervention in which the brain-spinal cord-muscle pathways are strengthened in individuals with incomplete spinal cord injury. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot.
Control GroupCombination product
This is the control intervention, or the non-conditioning group. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot.
| Study group | Role | What they receive |
|---|---|---|
| Up-conditioning (UC) Group | Experimental | Not described Receives: Combination Product: Operant Conditioning |
| Control (NC) Group | Sham comparator | Not described Receives: Combination Product: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the MEP recruitment curve--Studied Leg
An increased maximum MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
Measured: Baseline through 3 months post intervention
Change in the cortical map of the Tibialis Anterior: identifying the size (cm2) of the area of the brain that controls the tibialis anterior, the muscle that raises the toes and foot--Studied Leg
Reorganization of the TA cortical map would suggest that operant conditioning of the muscle response changes the brain. Knowing if and how the brain changes will help investigators understand the potential impact of this type of training.
Measured: Baseline through 3 months post intervention
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the spinal-cord level as measured by the Cervicomedullary MEP (CMEP) size--Studied Leg
An increase in the size of the CMEP (mV) elicited at a fixed stimulus intensity would indicate increased excitability/strength at the spinal cord level
Measured: Baseline through 3 months post intervention
Change in excitability of the excitability of the brain as measured by Short Interval Intra-cortical Inhibition (SICI)
Decreased SICI indicates increased excitability in the brain
Measured: Baseline through 3 months post intervention
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Studied Leg
Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
Measured: Baseline through 3 months post intervention
Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Studied Leg
Increased F-wave amplitude and/or occurrence indicates increased excitability/strength of the spinal cord-muscle pathway
Measured: Baseline through 3 months post intervention
Change in the ability to activate the muscle that lifts the toes during the swing-phase of walking as measured by tibialis anterior EMG amplitude (mv)--Studied Leg
Increased EMG amplitude indicates greater activation of the muscle, which could indicate an increased ability to lift the toes during the swing-phase of walking
Measured: Baseline through 3 months post intervention
Change in ankle joint motion during walking (deg)--Studied Leg
Ankle range of motion over the step cycle (in deg); Ankle peak flexion angle (in deg); Ankle angle at foot contact (in deg); Median ankle angle over the step cycle (in deg)
Measured: Baseline through 3 months post intervention
Change in walking speed (m/s) as measured by the 10-meter walk test
Speed of the participant's fastest comfortable walking speed across 10 meters. Decreased time (sec) demonstrates increased walking speed (m/s)
Measured: Baseline through 3 months post intervention
Change in walking distance (meters) as measured by the 6-minute walk test
The distance walked in 6 minutes in measured. The participant is asked to walk at his/her fastest comfortable speed on an indoor walkway.
Measured: Baseline through 3 months post intervention
Secondary outcomes (10)
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the MEP recruitment curve--Contralateral Leg
An increased maximum MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
Measured: Baseline through 3 months post intervention
Change in the cortical map of the Tibialis Anterior: identifying the size (cm2) of the area of the brain that controls the tibialis anterior, the muscle that raises the toes and foot--Contralateral Leg
Reorganization of the TA cortical map would suggest that operant conditioning of the muscle response changes the brain. Knowing if and how the brain changes will help investigators understand the potential impact of this type of training.
Measured: Baseline through 3 months post intervention
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the spinal-cord level as measured by the Cervicomedullary MEP (CMEP) size--Contralateral Leg
An increase in the size of the CMEP (mV) elicited at a fixed stimulus intensity would indicate increased excitability/strength at the spinal cord level
Measured: Baseline through 3 months post intervention
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Contralateral Leg
Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
Measured: Baseline through 3 months post intervention
Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Contralateral Leg
Increased F-wave amplitude and/or occurrence indicates increased excitability/strength of the spinal cord-muscle pathway
Measured: Baseline through 3 months post intervention
Change in the ability to activate the muscle that lifts the toes during the swing-phase of walking as measured by tibialis anterior EMG amplitude (mv)--Contralateral Leg
Increased EMG amplitude indicates greater activation of the muscle, which could indicate an increased ability to lift the toes during the swing-phase of walking
Measured: Baseline through 3 months post intervention
Change in ankle joint motion during walking (deg)--Studied Leg
Ankle range of motion over the step cycle (in deg); Ankle peak flexion angle (in deg); Ankle angle at foot contact (in deg); Median ankle angle over the step cycle (in deg)
Measured: Baseline through 3 months post intervention
Change in knee joint motion during walking (deg)--Both Legs
Knee range of motion over the step cycle (in deg); knee peak flexion angle (in deg); knee peak extension angle (in deg); knee angle at foot contact (in deg); median knee angle over the step cycle (in deg)
Measured: Baseline through 3 months post intervention
Change in hip joint motion during walking (deg)--Both Legs
Hip range of motion over the step cycle (in deg); hip peak flexion angle (in deg); hip peak extension angle (in deg); hip angle at foot contact (in deg); median hip angle over the step cycle (in deg)
Measured: Baseline through 3 months post intervention
Changes in reflexes and muscle activation during walking as measured by H-reflex size and cutaneous reflex size
Decreased H-reflex response and decreased radiating threshold of the cutaneous reflex would reflect reflex activity that is more similar to individuals without neurological injury
Measured: Baseline through 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start22 Feb 2021
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Aiko Thompson, Medical University of South Carolina
- Investigators
- Aiko K Thompson, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286191
- Sponsor's protocol ID
- 00091457
- Other IDs
- 1R01NS114279-01
- Status last verified
- Dec 2025
- First submitted
- 24 Feb 2020
- Last updated
- 9 Dec 2025
- Results posted
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Physiological Changes Induced Through Motor-evoked Potential Conditioning in People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04286191
- Acronym / sponsor ID
- 00091457
- Keywords
- Corticospinal Tract, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 26 Feb 2020 (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 study team is currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. After spinal cord injury, brain-to-muscle connections are often interrupted. Because these connections are important in movement control, when they are not working well, movements may be disturbed. Researchers have found that people can learn to strengthen these connections through training. Strengthening these connections may be able to improve movement control and recovery after injuries.
Research participants will be asked to stand, sit, and walk during the study sessions. Electrodes are placed on the skin over leg muscles for monitoring muscle activity. For examining brain-to-muscle connections, the study team will use transcranial magnetic stimulation. The stimulation is applied over the head and will indirectly stimulate brain cells with little or no discomfort.
Participation in this study requires approximately three sessions per week for four months, followed by two to three sessions over another three months. Each session lasts approximately 1 hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Up-conditioning (UC) Group | Experimental | Combination Product: Operant Conditioning |
| Control (NC) Group | Sham comparator | Combination Product: Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Neurologically stable (>1 year post SCI)
- Medical clearance to participate
- Ability to ambulate at least 10 m with or without an assistive device (except for parallel bars)
- Signs of weak ankle dorsiflexion at least unilaterally
- Expectation that current medication will be maintained without change for at least 3 months; stable use of anti-spasticity medication is accepted
Key exclusion criteria (11 listed)
- motoneuron injury
- known cardiac condition (e.g., history of myocardial infarction, congestive heart failure, pacemaker use)
- medically unstable condition
- cognitive impairment
- history of epileptic seizures
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 |
|---|---|---|
| Operant ConditioningThis is a training intervention in which the brain-spinal cord-muscle pathways are strengthened in individuals with incomplete spinal cord injury. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot. | Combination product | Up-conditioning (UC) Group |
| Control GroupThis is the control intervention, or the non-conditioning group. Transcranial magnetic stimulation (TMS), a type of brain stimulation, will be used to elicit a muscle response from the tibialis anterior (TA), the muscle that lifts your toes and foot. | Combination product | Control (NC) Group |
Primary outcome
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the MEP recruitment curve--Studied Leg
Time frame: Baseline through 3 months post intervention
An increased maximum MEP size (mV) would indicate increased excitability/strength of the brain-spinal cord-muscle pathway
Change in the cortical map of the Tibialis Anterior: identifying the size (cm2) of the area of the brain that controls the tibialis anterior, the muscle that raises the toes and foot--Studied Leg
Time frame: Baseline through 3 months post intervention
Reorganization of the TA cortical map would suggest that operant conditioning of the muscle response changes the brain. Knowing if and how the brain changes will help investigators understand the potential impact of this type of training.
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the spinal-cord level as measured by the Cervicomedullary MEP (CMEP) size--Studied Leg
Time frame: Baseline through 3 months post intervention
An increase in the size of the CMEP (mV) elicited at a fixed stimulus intensity would indicate increased excitability/strength at the spinal cord level
Change in excitability of the excitability of the brain as measured by Short Interval Intra-cortical Inhibition (SICI)
Time frame: Baseline through 3 months post intervention
Decreased SICI indicates increased excitability in the brain
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Studied Leg
Time frame: Baseline through 3 months post intervention
Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Studied Leg
Time frame: Baseline through 3 months post intervention
Increased F-wave amplitude and/or occurrence indicates increased excitability/strength of the spinal cord-muscle pathway
Change in the ability to activate the muscle that lifts the toes during the swing-phase of walking as measured by tibialis anterior EMG amplitude (mv)--Studied Leg
Time frame: Baseline through 3 months post intervention
Increased EMG amplitude indicates greater activation of the muscle, which could indicate an increased ability to lift the toes during the swing-phase of walking
Change in ankle joint motion during walking (deg)--Studied Leg
Time frame: Baseline through 3 months post intervention
Ankle range of motion over the step cycle (in deg); Ankle peak flexion angle (in deg); Ankle angle at foot contact (in deg); Median ankle angle over the step cycle (in deg)
Change in walking speed (m/s) as measured by the 10-meter walk test
Time frame: Baseline through 3 months post intervention
Speed of the participant's fastest comfortable walking speed across 10 meters. Decreased time (sec) demonstrates increased walking speed (m/s)
Change in walking distance (meters) as measured by the 6-minute walk test
Time frame: Baseline through 3 months post intervention
The distance walked in 6 minutes in measured. The participant is asked to walk at his/her fastest comfortable speed on an indoor walkway.
10 secondary outcomes
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the MEP recruitment curve--Contralateral Leg
Time frame: Baseline through 3 months post intervention
Change in the cortical map of the Tibialis Anterior: identifying the size (cm2) of the area of the brain that controls the tibialis anterior, the muscle that raises the toes and foot--Contralateral Leg
Time frame: Baseline through 3 months post intervention
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the spinal-cord level as measured by the Cervicomedullary MEP (CMEP) size--Contralateral Leg
Time frame: Baseline through 3 months post intervention
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation--Contralateral Leg
Time frame: Baseline through 3 months post intervention
Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Contralateral Leg
Time frame: Baseline through 3 months post intervention
Change in the ability to activate the muscle that lifts the toes during the swing-phase of walking as measured by tibialis anterior EMG amplitude (mv)--Contralateral Leg
Time frame: Baseline through 3 months post intervention
Change in ankle joint motion during walking (deg)--Studied Leg
Time frame: Baseline through 3 months post intervention
Change in knee joint motion during walking (deg)--Both Legs
Time frame: Baseline through 3 months post intervention
Change in hip joint motion during walking (deg)--Both Legs
Time frame: Baseline through 3 months post intervention
Changes in reflexes and muscle activation during walking as measured by H-reflex size and cutaneous reflex size
Time frame: Baseline through 3 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- 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.
Aiko K Thompson, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operant Conditioning in people with Spinal Cord Injuries and Neurological Injury, run by Medical University of South Carolina 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 9 Dec 2025. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the excitability/strength of the brain-spinal cord-muscle pathway at the brain level as measured by the MEP recruitment curve--Studied Leg (time frame: Baseline through 3 months post intervention). The study lists 10 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 9 Dec 2025.