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:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT06596369
Eligibility Criteria:
Inclusion Criteria:
SCI cohort:
* individuals aged 18 to 75 years of age who have suffered a spinal cord injury
* cervical level injury (C3 to C8)
* at least 1-year post-injury
* for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior to screening
Stroke cohort:
* individuals aged 18-75 years of age who have suffered any type of stroke resulting in upper extremity motor dysfunction with partially preserved motor function
* ≥ 6 months post-stroke
* At least 4 months since last BoNT injection for treatment of spasticity or any other condition or ≤ 2 months after study completion
* for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior to screening
Exclusion Criteria:
* pregnant women
* aphasia or dysphasia
* spasticity grade Modified Ashworth Scale ≥ 3
Transcranial magnetic stimulation-specific exclusion criteria (both cohorts)
* participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
* participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
* participants with a history of seizures or epilepsy
* participants taking any medication which may reduce seizure threshold
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06596369
Study Brief:
Protocol Section:
NCT06596369