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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT05457205
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* History of SCI (ASIA Impairment Scale grades A-D)
* Time since injury longer than 6 months
* The presence of at least mild spasticity (\>3) in the lower limbs by self-report of the Numerical Rating Scale (from 0 to 10) of spasticity severity
* Signed consent form
Exclusion Criteria:
* Neurological level of SCI below T11
* Suspected progression of SCI (e.g., syringomyelia)
* Ventilatory-dependent
* Implanted active devices (e.g., intrathecal baclofen pumps)
* Passive implants (plates, screws) between T10 and L3 vertebras
* Skin conditions precluding placement of electrodes
* Ongoing infections
* Pregnancy
* Difficulty following instructions
* No access to a caregiver/family member to help with electrode placement at home
* Other medical risks/contraindications as determined by the study physicians
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05457205
Study Brief:
Protocol Section:
NCT05457205