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Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI

Primary Purpose

Spinal Cord Injuries, Spine Disease, Stroke

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lidocaine Cream 5%

Rehabilitation Movement Training

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Rehabilitation, Numbing, temporary deafferentation-induced cortical plasticity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

SCI Patients:

Pacemaker or another implanted device
Metal in the skull
History of seizures
Pregnancy
First-degree relative with medication-resistant epilepsy
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Current use of illicit drugs, abusing alcohol, or have withdrawn from alcohol in the last 6 months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

Sites / Locations

University of Texas Rio Grande ValleyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Lidocaine Cream 5%

Rehabilitation Movement Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05589402

First Posted

June 23, 2022

Last Updated

October 17, 2022

Sponsor

University of Texas Rio Grande Valley

1. Study Identification

Unique Protocol Identification Number

NCT05589402

Brief Title

Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI

Official Title

Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 4, 2019 (Actual)

Primary Completion Date

June 4, 2023 (Anticipated)

Study Completion Date

June 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Texas Rio Grande Valley

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Spine Disease, Stroke

Keywords

Rehabilitation, Numbing, temporary deafferentation-induced cortical plasticity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine Cream 5%

Arm Type

Experimental

Arm Description

Arm Title

Rehabilitation Movement Training

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lidocaine Cream 5%

Other Intervention Name(s)

Ebanel, UBER NUMB

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Rehabilitation Movement Training

Intervention Description

reaching tasks, hand exercises (e.g., putty, grip exerciser, resistance bands, etc).

Primary Outcome Measure Information:

Title

Electromyography (EMG)

Description

Time Frame

Throughout Study Duration, an average of four weeks

Title

Transcranial Magnetic Stimulation (TMS)

Description

Time Frame

Throughout Study Duration, an average of four weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: SCI Patients: Pacemaker or another implanted device Metal in the skull History of seizures Pregnancy First-degree relative with medication-resistant epilepsy 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Salinas, BS

Phone

9562962014

daniel.salinas02@utrgv.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kelsey Baker

Phone

9562961337

kelsey.baker@utrgv.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelsey Baker

Organizational Affiliation

University of Texas Rio Grande Valley

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Rio Grande Valley

City

Harlingen

State/Province

Texas

ZIP/Postal Code

78550

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelsey Baker, PhD

Phone

956-296-1337

kelsey.baker@utrgv.edu

First Name & Middle Initial & Last Name & Degree

Nora Campos

Phone

9562965525

nora.campos@utrgv.edu

First Name & Middle Initial & Last Name & Degree

Kelsey Baker, PhD

First Name & Middle Initial & Last Name & Degree

Daniel Salinas, BS

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Deidentified data may be shared with interested researchers upon request. There is not a formal sharing plan in place.

Learn more about this trial

Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI

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