Spinal Cord InjuriesPhase 1NCT05589402
Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI
A Phase 1 study testing Lidocaine Cream 5% and Rehabilitation Movement Training in people with Spinal Cord Injuries and Spine Disease, run by University of Texas Rio Grande Valley at 1 site in United States.
Trial summary
The investigators are conducting a research study to try to improve rehabilitation interventions for individuals with spinal cord injury (SCI). In this study, the aim is to determine if temporarily numbing non-paralyzed arm muscles with an over-the-counter numbing cream while exercising paralyzed muscles, can improve… 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, Spine Disease, Stroke
- What is being tested?
- Lidocaine Cream 5% and Rehabilitation Movement Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2019to 15 Jul 2026
- Phase
- Phase 1
- 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
Who may be able to join
- SCI Patients:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged between 18 and 75 years old
- Have physician diagnosed cervical incomplete spinal cord injury or lesion (iSCI)
- Classified by the American Spinal Cord Association (AIS) impairment scale as AIS C or D
Show all 21Show fewer
- iSCI occurred at least 18 months ago
- Level of injury or lesion is between C2 and T1
- Bicep strength must be classified as ≥ 3 muscle grade as defined by the medical research council scale
- Tricep strength must be at least an MRC grade of 2 and bet at least 1 muscle grade lower than the bicep
- Both the biceps and triceps will be required to elicit an active motor evoked potential >200 uV with transcranial magnetic stimulation
- Must maintain current medication regime
- Must present with a weaker side of the body, as indicated by a Upper extremity motor score difference between the left and right side
- UEMS < 40 (50 max score)
- Must be able to perform reaching movement training task
- Healthy Controls:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged between 18 and 75 years old
- Must be right-handed
- Must be able to perform hand exercises
Who cannot join
- SCI Patients:
- Pacemaker or another implanted device
- Metal in the skull
- History of seizures
- Pregnancy
- First-degree relative with medication-resistant epilepsy
Show all 32Show fewer
- Current participation in upper limb rehabilitation therapies
- Current use of illicit drugs, abusing alcohol, or have withdrawn from alcohol in the last 6 months
- Other neurological impairment or condition
- Pressure ulcers
- Significant lower motor neuron loss at C7 as noted by a nerve conduction velocity <50 m/s
- History of traumatic brain injury as documented by Rancho Scale Impairment of <5
- History of brain MRI documented focal cerebral cortex infarct (e.g. hydrocephalus)
- Contractures at the elbow
- Severe spasticity as noted by a modified ashworth scale (MAS) > 4
- Documented, non-sedated post-traumatic amnesia lasting more than 48 hours
- Pregnancy
- Allergic to lidocaine
- A neuroactive medication that has the potential to lower the seizure threshold
- Based on documented publications in stroke, this will include bupropion (wellbutrin), psychostimulants and neuroleptics
- All medications will be reviewed with physician, Dr. Amol Utturkar (DHR)
- Healthy Controls:
- Pacemaker or other implanted device
- Metal in the skull
- History of seizures
- First-degree relative with medication-resistant epilepsy
- Current use of illicit drugs (including heroin, crack/cocaine, marijuana), abusing alcohol or having withdrawn from alcohol in the last 6 months
- Allergy to lidocaine
- Other neurological impairment or condition
- Pregnancy
- A neuroactive medication that has the potential to lower the seizure threshold
- Based on documented publications on stroke, this will include bupropion (wellbutrin), psychostimulants and neuroleptics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Rio Grande Valley
Harlingen, Texas, 78550
About this study
The investigators are conducting a research study to try to improve rehabilitation interventions for individuals with spinal cord injury (SCI). In this study, the aim is to determine if temporarily numbing non-paralyzed arm muscles with an over-the-counter numbing cream while exercising paralyzed muscles, can improve the strength, function, and sensation of paralyzed muscles after a spinal cord injury.
Read the detailed description
The functional benefits of temporary deafferentation (numbing)-induced cortical plasticity have been demonstrated in individuals with stroke, nerve damage, and pain syndromes. Of note, documented benefits have included improvements in motor function and touch perception in the weaker muscles. For example, Weiss et al demonstrated that temporary deafferentation to the forearm of the paretic limb in stroke for two hours during movement therapy improved motor performance of the hand by 10 to 48% after a single session. Another study established that bi-weekly sessions of temporary deafferentation for two weeks improved two-point discrimination and touch perception in individuals with ulnar/median nerve damage. More importantly, the authors found that improvements were retained for more than four weeks after the intervention ended. Collectively, this suggests that the release of tonic inhibition on weak muscle pathways, through temporary deafferentation, can lead to functional benefits that are retained long-term.
The Investigators' pilot findings indicate that temporary deafferentation shows similar benefits in the population of SCI. Specifically, it was observed that a single 30-minute session of temporary deafferentation to the stronger biceps can improve excitability to the weaker triceps and result in gains in hand dexterity and pinch strength in SCI.
The Investigators now seek to optimize the current study protocol before a large-scale clinical trial is conducted.
- Conditions
- Spinal Cord Injuries, Spine Disease, Stroke
- Being tested
- Lidocaine Cream 5%, Rehabilitation Movement Training
- Keywords
- Rehabilitation, Numbing, temporary deafferentation-induced cortical plasticity
- Medical subject headings
- Spinal Cord Injuries, Spinal Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Cream 5%Drug
Also called Ebanel, UBER NUMB
Ebanel 5% Lidocaine Topical Numbing Cream Maximum Strength 1.35 Oz, Numb520 Pain Relief Cream Anesthetic Cream Infused with Aloe Vera, Vitamin E, Lecithin, Allantoin, Secured with Child Resistant Cap
Rehabilitation Movement TrainingOther
reaching tasks, hand exercises (e.g., putty, grip exerciser, resistance bands, etc).
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Cream 5% | Experimental | A topical anesthetic will be used to deliver temporary inactivation of muscle sensation. Specifically, due to its high safety profile, Lidocaine Cream 5% will be used in the current sub-study. Lidocaine cream (5%) is FDA-approved and available over-the-counter. The investigators will apply the lidocaine cream 5% following FDA guidelines and previously published protocol methodology. A test will be utilized to evaluate if the approach provides complete and temporary inactivation of sensation from the biceps. The von Frey filament test will be used with filaments ranging in size (1,65 to 6,65) to be placed on the biceps muscle every 15 minutes after lidocaine application.
Based on published work, and the current investigators' pilot data, it is anticipated that all sensations from the biceps should be blocked approximately 30 to 60 minutes after lidocaine application. Complete temporary inactivation will be defined at the point when all baseline sensation can no longer be achieved. Receives: Drug: Lidocaine Cream 5% |
| Rehabilitation Movement Training | Other | During temporary deafferentation, subjects will perform movement training. Similar to other single-session studies, the current investigators chose to pair the paradigm with movement training to bolster the effects of the approach.
A reaching task that is commonly performed in rehabilitation will be used. Task practice will be performed for 1 hour, with breaks given every 10 minutes. Past experiments in the current investigators' lab have adopted a similar protocol for task practice in SCI and found no adverse events. Movement training will also be assisted by the Bionik InMotion Arm/Hand robot, which has been studied in clinical and rehabilitative practices for over 20 years.
Movement training at 1 hour will be ceased due to issues with fatigue, as has been noted in previous SCI clinical studies. In addition, published work suggests that lidocaine has a half-life of one 1 hour. Thus, maximum benefits should be achieved at the 1-hour mark after application. Receives: Other: Rehabilitation Movement Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (EMG)
The investigators will use an electrical stimulator to send an electrical signal to a target muscle to initiate contraction, and an Electromyography (EMG) will be used to record the changes in target muscle response from baseline, pre-test, and post-test.
An electronic nerve stimulator will output a pulse ranging from 0 mV to 2 mV for an appropriate maximum muscle contraction to occur, and an Electromyography (EMG in root mean square) will capture the muscle's contraction via surface electrodes. A greater number of Root Mean Square (RMS) millivoltage registered on the EMG signifies a higher response from the muscle, additionally, any plateau of the RMS while administering higher mV from the Stimulator will signify a maximum contraction of the muscle.
Measured: Throughout Study Duration, an average of four weeks
Transcranial Magnetic Stimulation (TMS)
Using Transcranial Magnetic Stimulation (TMS) to promote Motor Evoked Potentials (MEP), the Investigators will monitor changes in cortical excitability of the target muscle's motor hotspot by measuring the muscle excitability with Electromyography (EMG; in millivolts) from Baseline, Pre-test, and at Post-test.
The motor hotspot of the weak muscle will be defined as the site that evokes MEPs ≥50 mV at the lowest intensity (% device output), or the resting motor threshold (RMT). A decrease of the TMS's percentage output to promote MEPs of the weak muscle signifies a decrease in the cortical excitability, as measured by Active Motor Thresholds (AMT) and Active Motor Evoked Potentials (AMEP).
Measured: Throughout Study Duration, an average of four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start4 Jun 2019
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Rio Grande Valley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelsey Baker, Principal investigator, University of Texas Rio Grande Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589402
- Sponsor's protocol ID
- IRB-18-0596
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2022
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data may be shared with interested researchers upon request. There is not a formal sharing plan in place.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI
- ClinicalTrials.gov ID
- NCT05589402
- Acronym / sponsor ID
- IRB-18-0596
- Conditions
- Spinal Cord Injuries, Spine Disease, Stroke
- Keywords
- Rehabilitation, Numbing, temporary deafferentation-induced cortical plasticity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Texas Rio Grande ValleyUniversity, hospital or other
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 21 Oct 2022 (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 investigators are conducting a research study to try to improve rehabilitation interventions for individuals with spinal cord injury (SCI). In this study, the aim is to determine if temporarily numbing non-paralyzed arm muscles with an over-the-counter numbing cream while exercising paralyzed muscles, can improve the strength, function, and sensation of paralyzed muscles after a spinal cord injury.
Detailed description
The functional benefits of temporary deafferentation (numbing)-induced cortical plasticity have been demonstrated in individuals with stroke, nerve damage, and pain syndromes. Of note, documented benefits have included improvements in motor function and touch perception in the weaker muscles. For example, Weiss et al demonstrated that temporary deafferentation to the forearm of the paretic limb in stroke for two hours during movement therapy improved motor performance of the hand by 10 to 48% after a single session. Another study established that bi-weekly sessions of temporary deafferentation for two weeks improved two-point discrimination and touch perception in individuals with ulnar/median nerve damage. More importantly, the authors found that improvements were retained for more than four weeks after the intervention ended. Collectively, this suggests that the release of tonic inhibition on weak muscle pathways, through temporary deafferentation, can lead to functional benefits that are retained long-term.
The Investigators' pilot findings indicate that temporary deafferentation shows similar benefits in the population of SCI. Specifically, it was observed that a single 30-minute session of temporary deafferentation to the stronger biceps can improve excitability to the weaker triceps and result in gains in hand dexterity and pinch strength in SCI.
The Investigators now seek to optimize the current study protocol before a large-scale clinical trial is conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Cream 5% | Experimental | Drug: Lidocaine Cream 5%A topical anesthetic will be used to deliver temporary inactivation of muscle sensation. Specifically, due to its high safety profile, Lidocaine Cream 5% will be used in the current sub-study. Lidocaine cream (5%) is FDA-approved and available over-the-counter. The investigators will apply the lidocaine cream 5% following FDA guidelines and previously published protocol methodology. A test will be utilized to evaluate if the approach provides complete and temporary inactivation of sensation from the biceps. The von Frey filament test will be used with filaments ranging in size (1,65 to 6,65) to be placed on the biceps muscle every 15 minutes after lidocaine application. Based on published work, and the current investigators' pilot data, it is anticipated that all sensations from the biceps should be blocked approximately 30 to 60 minutes after lidocaine application. Complete temporary inactivation will be defined at the point when all baseline sensation can no longer be achieved. |
| Rehabilitation Movement Training | Other | Other: Rehabilitation Movement TrainingDuring temporary deafferentation, subjects will perform movement training. Similar to other single-session studies, the current investigators chose to pair the paradigm with movement training to bolster the effects of the approach. A reaching task that is commonly performed in rehabilitation will be used. Task practice will be performed for 1 hour, with breaks given every 10 minutes. Past experiments in the current investigators' lab have adopted a similar protocol for task practice in SCI and found no adverse events. Movement training will also be assisted by the Bionik InMotion Arm/Hand robot, which has been studied in clinical and rehabilitative practices for over 20 years. Movement training at 1 hour will be ceased due to issues with fatigue, as has been noted in previous SCI clinical studies. In addition, published work suggests that lidocaine has a half-life of one 1 hour. Thus, maximum benefits should be achieved at the 1-hour mark after application. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged between 18 and 75 years old
- Have physician diagnosed cervical incomplete spinal cord injury or lesion (iSCI)
- Classified by the American Spinal Cord Association (AIS) impairment scale as AIS C or D
Key exclusion criteria (32 listed)
- Pacemaker or another implanted device
- Metal in the skull
- History of seizures
- Pregnancy
- First-degree relative with medication-resistant 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 |
|---|---|---|
| Lidocaine Cream 5%Also: Ebanel, UBER NUMBEbanel 5% Lidocaine Topical Numbing Cream Maximum Strength 1.35 Oz, Numb520 Pain Relief Cream Anesthetic Cream Infused with Aloe Vera, Vitamin E, Lecithin, Allantoin, Secured with Child Resistant Cap | Drug | Lidocaine Cream 5% |
| Rehabilitation Movement Trainingreaching tasks, hand exercises (e.g., putty, grip exerciser, resistance bands, etc). | Other | Rehabilitation Movement Training |
Primary outcome
Electromyography (EMG)
Time frame: Throughout Study Duration, an average of four weeks
The investigators will use an electrical stimulator to send an electrical signal to a target muscle to initiate contraction, and an Electromyography (EMG) will be used to record the changes in target muscle response from baseline, pre-test, and post-test. An electronic nerve stimulator will output a pulse ranging from 0 mV to 2 mV for an appropriate maximum muscle contraction to occur, and an Electromyography (EMG in root mean square) will capture the muscle's contraction via surface electrodes. A greater number of Root Mean Square (RMS) millivoltage registered on the EMG signifies a higher response from the muscle, additionally, any plateau of the RMS while administering higher mV from the Stimulator will signify a maximum contraction of the muscle.
Transcranial Magnetic Stimulation (TMS)
Time frame: Throughout Study Duration, an average of four weeks
Using Transcranial Magnetic Stimulation (TMS) to promote Motor Evoked Potentials (MEP), the Investigators will monitor changes in cortical excitability of the target muscle's motor hotspot by measuring the muscle excitability with Electromyography (EMG; in millivolts) from Baseline, Pre-test, and at Post-test. The motor hotspot of the weak muscle will be defined as the site that evokes MEPs ≥50 mV at the lowest intensity (% device output), or the resting motor threshold (RMT). A decrease of the TMS's percentage output to promote MEPs of the weak muscle signifies a decrease in the cortical excitability, as measured by Active Motor Thresholds (AMT) and Active Motor Evoked Potentials (AMEP).
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 31 Jul 2026.
- Individual participant dataSharing planned: No. Deidentified data may be shared with interested researchers upon request. There is not a formal sharing plan in place.
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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.
Kelsey Baker principal investigator
University of Texas Rio Grande Valley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine Cream 5% and Rehabilitation Movement Training in people with Spinal Cord Injuries and Spine Disease, run by University of Texas Rio Grande Valley 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 21 inclusion and 32 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 31 Jul 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Electromyography (EMG) (time frame: Throughout Study Duration, an average of four weeks). 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 31 Jul 2026.