Numbing arm muscles to enhance rehabilitation for spinal cord injury
Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI
This study is testing if using a numbing cream on arm muscles can help people with spinal cord injuries improve their strength and movement during rehabilitation exercises.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Texas Rio Grande Valley Academic / other |
| Locations | 1 site (Harlingen, Texas) |
| Trial ID | NCT05589402 on ClinicalTrials.gov |
What this trial studies
This study aims to improve rehabilitation interventions for individuals with spinal cord injuries by temporarily numbing non-paralyzed arm muscles using an over-the-counter numbing cream while exercising paralyzed muscles. The approach is based on the concept of temporary deafferentation-induced cortical plasticity, which has shown benefits in improving motor function and sensation in other populations. The investigators will assess the effects of this intervention on muscle strength, function, and sensation in patients with spinal cord injuries. The study will optimize the protocol before a larger clinical trial is conducted.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with cervical incomplete spinal cord injuries classified as AIS C or D, who have a weaker side and meet specific muscle strength criteria.
Not a fit: Patients with complete spinal cord injuries or those whose injuries occurred less than 18 months ago may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for patients with spinal cord injuries.
How similar studies have performed: Previous studies have shown success with similar temporary deafferentation approaches in other populations, suggesting potential for this method in spinal cord injury rehabilitation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Harlingen, Texas
- University of Texas Rio Grande Valley — Harlingen, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kelsey Baker — University of Texas Rio Grande Valley
- Study coordinator: Daniel Salinas, BS
- Email: daniel.salinas02@utrgv.edu
- Phone: 9562962014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.