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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07377305
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with NMOSD in accordance with the criteria of the International Panel for Neuromyelitis Optica Diagnosis (IPND).
* Patients were complicated with neuropathic pain, with a DN4 score ≥ 4.
* NRS score for pain ≥ 4 points, and neuropathic pain has persisted for more than 3 months.
* Patients receiving biological therapy and/or prednisone at a stable dose, with no adjustment of the treatment plan within 30 days before enrollment.
* Patients who have not adjusted any combination of standard analgesic drugs (including antiepileptic drugs, antidepressants, and opioid drugs) within 30 days before enrollment.
* Patients or their family members who have signed a written informed consent form.
Exclusion Criteria:
* Subjects participating in other clinical studies.
* Subjects who have used investigational drugs for pain control within 30 days before enrollment.
* Subjects with a concurrent diagnosis of peripheral neuropathy.
* Subjects with concurrent active central nervous system diseases.
* Subjects with cognitive or mental disorders.
* Subjects who are pregnant, lactating, or planning to become pregnant during the study period.
* Subjects with severe diseases related to the heart, liver, kidneys, or hematopoietic system.
* Subjects with implanted devices in the body (such as cardiac pacemakers, nerve stimulators, etc.).
* Subjects with a history of transcutaneous electrical nerve stimulation (TENS) allergy, latex allergy, or previous intolerance.
* Subjects with contraindications to MRI examination.
* Subjects with head skin lesions.
* Other medical conditions or situations that the researcher deems may affect the achievement of the study objectives.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07377305
Study Brief:
Protocol Section:
NCT07377305