Stroke Clinical Trial
Official title:
Temporary Inactivation of Strong Muscle Sensation to Improve Rehabilitation Interventions in SCI
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 | Recruiting |
Enrollment | 30 |
Est. completion date | June 4, 2025 |
Est. primary completion date | June 4, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Rio Grande Valley | Harlingen | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Rio Grande Valley |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Throughout Study Duration, an average of four weeks | |
Primary | 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). |
Throughout Study Duration, an average of four weeks |
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