Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI
Completed · Phase 1
Conditions studied: Spinal Cord Injuries, Spine Disease, Stroke
In brief
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.
Key facts
- Study ID
- NCT05589402
- Run by
- University of Texas Rio Grande Valley
- People needed
- 52
- Starts
- 2019-06-04
- Expected to finish
- 2026-07-15
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Texas Rio Grande Valley — Harlingen, Texas, United States
Full record on ClinicalTrials.gov
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