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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03592394
Eligibility Criteria:
Inclusion Criteria:
* Presence of chronic neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord;
* A pain intensity of at least 4 out of 10 in the numerical rating scale (NRS) in the Neuropathic Pain Scale (NPS) test at both screening (baseline) and randomization (pre-evaluation);
* Stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial;
* Incomplete lesion (American Spinal Injury Association Impairment Scale, AIS B, C or D; B= motor complete, sensory incomplete; C= sensorimotor incomplete with an average strength of the muscles below the level of the lesion \<3, D= sensorimotor incomplete with average muscle strength \>3);
* Cervical level of lesion (C2 to T1) with presence of pain in the upper extremities
Exclusion Criteria:
* Presence of severe pain of other origin, such as musculoskeletal pain
* Psychiatric or other neurological disorders
* Head injuries causing cognitive or visual impairment
* Severe vertigo
* Presence of potential risk factors for brain stimulation (TMS): history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull;
* Medically unstable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03592394
Study Brief:
Protocol Section:
NCT03592394