Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI (NCT05589402) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI
United States30 participantsStarted 2019-06-04
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Electromyography (EMG)
Timeframe: Throughout Study Duration, an average of four weeks
2
Transcranial Magnetic Stimulation (TMS)
Timeframe: Throughout Study Duration, an average of four weeks