Actively Recruiting
Evaluation of Transcranial Temporal Interference Stimulation for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder: A Single-center, Prospective, Single-arm Clinical Study
Led by Tang-Du Hospital · Updated on 2026-01-29
12
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neuromyelitis optica spectrum disorder (NMOSD) is a rare but serious condition mainly affecting adults, often accompanied by neuropathic pain which can be chronic and difficult to treat. This study aims to evaluate the safety and effectiveness of transcranial temporal interference stimulation (tTIS), a non-invasive brain stimulation technique, in patients with NMOSD who experience this type of pain. The study is an open-label, single-arm, single-center pilot trial conducted in China to explore this emerging therapy as an alternative to current limited pain treatments. Participants will receive tTIS targeting the ventral posterolateral nucleus on the side opposite to their pain. The stimulation uses a 10Hz envelope field with a current intensity ranging from 2 to 4mA, applied for 20 minutes daily over 5 consecutive days. This intervention is designed to assess potential improvements in pain and neurological function by comparing several clinical pain and mood scales before and after treatment. During the study, patients will undergo assessments including the Numerical Rating Scale (NRS) for pain, Visual Analog Scale (VAS), Global Impression Scales, Short-Form McGill Pain Questionnaire, Painful Spasm Frequency Scale, and Hamilton Anxiety and Depression Scales. These measurements will be taken at baseline, immediately after treatment, and at 1- and 2-week follow-ups. Researchers will monitor adverse events throughout to evaluate the safety of tTIS. The total study duration extends from treatment through two weeks of follow-up to observe changes and potential benefits in neuropathic pain management.
CONDITIONS
Brief Title
Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with neuromyelitis optica spectrum disorder (NMOSD) according to International Panel for Neuromyelitis Optica Diagnosis (IPND) criteria
- Neuropathic pain with a DN4 score of 4 or higher
- Numerical Rating Scale (NRS) pain score of 4 or more, with pain lasting longer than 3 months
- Stable biological therapy and/or prednisone dose without changes for at least 30 days before enrollment
- No changes in standard analgesic drugs (antiepileptic, antidepressant, opioid) for at least 30 days before enrollment
- Provided written informed consent by the patient or family members
You will not qualify if you...
- Participation in other clinical studies
- Use of investigational drugs for pain control within 30 days before enrollment
- Diagnosis of peripheral neuropathy
- Presence of active central nervous system diseases
- Cognitive or mental disorders
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Severe heart, liver, kidney, or blood diseases
- Implanted devices such as pacemakers or nerve stimulators
- History of allergy or intolerance to transcutaneous electrical nerve stimulation (TENS) or latex
- Contraindications to MRI examination
- Head skin lesions
- Other medical conditions that may interfere with study goals as judged by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive transcranial temporal interference stimulation (tTIS) targeted at the ventral posterolateral nucleus for neuropathic pain treatment over 5 consecutive days.
5 daily visits (in-person)
Duration - 2 weeks
Participants are monitored for changes in pain and related symptoms after treatment, including safety assessments.
Visits immediately after treatment, 1 week after treatment, and 2 weeks after treatment
Trial Site Locations
Total: 1 location
1
Tangdu Hospital
Xi'an, Shaanxi, China, 710038
Actively Recruiting
Research Team
J
Jun GUO, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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