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NCT05589402CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
52 (actual)
First submitted
23 Jun 2022
Start date
4 Jun 2019
Primary completion date
15 Jul 2026
Lead sponsor
University of Texas Rio Grande Valley
Diseases
Stroke
NCT number
NCT05589402

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 52
  • From 4 Jun 2019 to the primary completion date, 15 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current participation in upper limb rehabilitation therapies
  • Current use of illicit drugs, abusing alcohol, or have withdrawn from alcohol in the last 6 months
  • Current use of illicit drugs (including heroin, crack/cocaine, marijuana), abusing alcohol or having withdrawn from alcohol in the last 6 months

Other illness

  • History of seizures
  • First-degree relative with medication-resistant epilepsy
  • Other neurological impairment or condition
  • 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)
  • 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:
  • History of seizures
  • First-degree relative with medication-resistant epilepsy
  • Allergy to lidocaine
  • Other neurological impairment or condition
  • 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

Other

  • SCI Patients:
  • Pacemaker or another implanted device
  • Metal in the skull
  • Pregnancy
  • Pressure ulcers
  • Significant lower motor neuron loss at C7 as noted by a nerve conduction velocity \<50 m/s
  • 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
  • Pacemaker or other implanted device
  • Metal in the skull
  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Texas Rio Grande Valley
Coordinator of this site? Confirm its status
HarlingenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.