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Tests treatment safety and results for NMO Spectrum Disorder
Official title Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)
ClinicalTrials.gov ID: NCT07377305
What this study is testing
- What it's testing
- This is an open-label, single-arm, single-center prospective pilot study to assess the efficacy and safety of transcranial temperol interference stimulation in patients with neuromyelitis optica spectrum disorder (NMOSD) complicated by neuropathic pain in China.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- people participating in other clinical studies.
- people who have used investigational drugs for pain control within 30 days before enrollment.
- people with a concurrent diagnosis of peripheral neuropathy.
- people with concurrent active central nervous system diseases.
- people with cognitive or mental disorders.
- people who are pregnant, lactating, or planning to become pregnant during the study period.
See the full eligibility 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.
- people participating in other clinical studies.
- people who have used investigational drugs for pain control within 30 days before enrollment.
- people with a concurrent diagnosis of peripheral neuropathy.
- people with concurrent active central nervous system diseases.
- people with cognitive or mental disorders.
- people who are pregnant, lactating, or planning to become pregnant during the study period.
- people with severe diseases related to the heart, liver, kidneys, or hematopoietic system.
- people with implanted devices in the body (such as cardiac pacemakers, nerve stimulators, etc.).
- people with a history of transcutaneous electrical nerve stimulation (TENS) allergy, latex allergy, or previous intolerance.
- people with contraindications to MRI examination.
- people with head skin lesions.
- Other medical conditions or situations that the researcher deems may affect the achievement of the study objectives.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.