Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05589402
Eligibility 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* Current use of illicit drugs, abusing alcohol, or have withdrawn from alcohol in the last 6 months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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05589402
Study Brief:
Protocol Section:
NCT05589402