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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT05522920
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to give informed consent for participation in the study
* Aged ≥18 years
* Injury level C3-C7, American Spinal Cord injury Association Impairment Scale (ASIA) A
* ≥1 year post-injury
* Medically stable, cognitively intact, and able to breathe independently
* Able to attend all sessions two or three times per week, for 2 h sessions and assessments
Exclusion Criteria:
* Any implanted active metallic device including, but not limited to neurostimulators, cochlear implants, pacemakers, implantable defibrillators, or drug delivery pumps
* Possible, suspected, or confirmed pregnancy and/or lactation
* Recent history or fracture, contractures or pressure sore, deep vein thrombosis (DVT) or urinary tract, or other infection that may interfere with the intervention and training
* History of epilepsy and/or seizures
* Severe spasticity which has been unstable over the 3 months prior to enrolment and is not expected to change and/or taking varying doses of anti-spasticity medications which could not be tapered to a stable dose and are not expected to change
* Botulinum toxin injections within 6 months of participation
* Non-injury related neurological impairment
* Clinically significant severe depression in spite of treatment
* Cardiovascular disease
* Autonomic dysreflexia that is severe, ongoing, and has required medical treatment within the past month
* Skin conditions or allergies that may affect electrode placement
* Do not understand English
* Received a stem cell treatment or other treatment that could possibly promote or attenuate neuroplastic changes in spinal or cortical function, within ≥2 years of enrolment; beyond this period, they may be included, provided the treatment was conducted in an accredited facility with proper ethics and regulatory approval.
* Involved in any other study involving stimulation of the spinal cord within 6 months of enrolment
* Information regarding recent rehabilitation or exercise programmes that participants may currently be engaged in will be discussed with clinical staff and fully documented for each participant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05522920
Study Brief:
Protocol Section:
NCT05522920