NMO Spectrum DisorderNCT07377305
Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)
A study testing 10Hz tTIS (2-4mA) Intervention in people with NMO Spectrum Disorder, run by Tang-Du Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NMO Spectrum Disorder
- What is being tested?
- 10Hz tTIS (2-4mA) Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
Jun GUO, Dr, (86)13991269132, guojun_81@163.com
About this study
Official title: A Single-center, Prospective, Single-arm Clinical Study: Evaluation of the Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)
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.
Read the detailed description
Neuromyelitis optica spectrum disorder (NMOSD) is a rare but severe demyelinating condition that affects mainly adult patients. In the course of NMOSD, pain is a common accompanying symptom, aside from other symptoms such as visual impairment, limb weakness, limb numbness, and urinary and fecal dysfunction. Among these, neuropathic pain is the most common, affecting over 80% of patients with NMOSD. It occurs not only during the acute phase of NMOSD but also serves as the main form of chronic pain. Currently, there is no standard clinical protocol for the treatment of neuropathic pain, and the efficacy of analgesic drugs is limited. Transcranial temporal interference stimulation (tTIS) is emerging as a non-invasive therapeutic alternative to deep brain stimulation (DBS). Studies have shown that tTIS exerts a positive impact on neural function, including enhancing memory function and improving motor function. While it still remains underdeveloped about tTIS in the field of pain management. Based on this, we intend to conduct a small-sample prospective self-controlled study. By analyzing the baseline clinical characteristics, we will compare the changes in pain scale scores (Numerical Rating Scale [NRS], Visual Analog Scale [VAS]), Global Impression Scales, Short-Form McGill Pain Questionnaire, Painful Spasm Frequency Scale, and Hamilton Anxiety/Depression Scale scores before and after tTIS treatment. Through this, we aim to evaluate the efficacy and safety of this therapeutic approach in subjects suffered from NMOSD-related neuropathic pain.
- Conditions
- NMO Spectrum Disorder
- Being tested
- 10Hz tTIS (2-4mA) Intervention
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10Hz tTIS (2-4mA) InterventionDevice
tTIS (10Hz envelope field, current intensity 2-4mA)
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Current Stimulation (tTIS) Targeting Ventral Posterolateral Nucleus for Pain Treatment | Experimental | tTIS (10Hz envelope field, current intensity 2-4mA) targeted at ventral posterolateral nucleus (contralateral to the pain side) for 5 consecutive days (20 minutes/ day) Receives: Device: 10Hz tTIS (2-4mA) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in numerical rating scale (NRS) score
Patients are followed up and NRS score is determined. In general, the minimum and maximum scores of NRS are 0 and 10, respectively, with higher scores meaning a worse outcome.
Measured: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Secondary outcomes (7)
Change from baseline in visual analog scale (VAS) score
Patients are followed up and VAS score is determined. In general, the minimum and maximum scores of VAS are 0 and 10, respectively, with higher scores meaning a worse outcome.
Measured: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in patient global impression of change (PGIC) score
Patients are followed up and PGIC score is determined. In general, the minimum and maximum scores of PGIC are 1 and 7, respectively, with higher scores meaning a worse outcome.
Measured: Immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in short-form McGill pain questionnaire (SF-MPQ) score
Patients are followed up and SF-MPQ score is determined. In general, the minimum and maximum scores of SF-MPQ are 0 and 45, respectively, with higher scores meaning a worse outcome.
Measured: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in Penn spasm frequency scale (PSFS) score
Patients are followed up and PSFS score is determined. In general, spasm frequency and spasm severity are evaluated. The minimum and maximum scores of spasm frequency are 0 and 4, respectively, with higher scores meaning a worse outcome. The minimum and maximum scores of spasm severity are 1 and 3, respectively, with higher scores meaning a worse outcome.
Measured: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in Hamilton anxiety rating scale (HAMA) score
Patients are followed up and HAMA score is determined. In general, the minimum and maximum scores of HAMA are 0 and 56, respectively, with higher scores meaning a worse outcome.
Measured: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in Hamilton depression rating scale (HAMD) score
Patients are followed up and HAMD score is determined. In general, the minimum and maximum scores of HAMD are 0 and 54, respectively, with higher scores meaning a worse outcome.
Measured: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Adverse events
tTIS-related adverse events (AEs), such as headache, scalp irritation, rash, epilepsy, are evaluated and the rate of AEs is recorded.
Measured: Baseline up to 2 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start8 Dec 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMO Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Guo, MD, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377305
- Sponsor's protocol ID
- K202512-50
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Single-arm Clinical Study: Evaluation of the Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)
- ClinicalTrials.gov ID
- NCT07377305
- Acronym / sponsor ID
- K202512-50
- Conditions
- NMO Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neuromyelitis optica spectrum disorder (NMOSD) is a rare but severe demyelinating condition that affects mainly adult patients. In the course of NMOSD, pain is a common accompanying symptom, aside from other symptoms such as visual impairment, limb weakness, limb numbness, and urinary and fecal dysfunction. Among these, neuropathic pain is the most common, affecting over 80% of patients with NMOSD. It occurs not only during the acute phase of NMOSD but also serves as the main form of chronic pain. Currently, there is no standard clinical protocol for the treatment of neuropathic pain, and the efficacy of analgesic drugs is limited. Transcranial temporal interference stimulation (tTIS) is emerging as a non-invasive therapeutic alternative to deep brain stimulation (DBS). Studies have shown that tTIS exerts a positive impact on neural function, including enhancing memory function and improving motor function. While it still remains underdeveloped about tTIS in the field of pain management. Based on this, we intend to conduct a small-sample prospective self-controlled study. By analyzing the baseline clinical characteristics, we will compare the changes in pain scale scores (Numerical Rating Scale [NRS], Visual Analog Scale [VAS]), Global Impression Scales, Short-Form McGill Pain Questionnaire, Painful Spasm Frequency Scale, and Hamilton Anxiety/Depression Scale scores before and after tTIS treatment. Through this, we aim to evaluate the efficacy and safety of this therapeutic approach in subjects suffered from NMOSD-related neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Current Stimulation (tTIS) Targeting Ventral Posterolateral Nucleus for Pain Treatment | Experimental | Device: 10Hz tTIS (2-4mA) InterventiontTIS (10Hz envelope field, current intensity 2-4mA) targeted at ventral posterolateral nucleus (contralateral to the pain side) for 5 consecutive days (20 minutes/ day) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10Hz tTIS (2-4mA) InterventiontTIS (10Hz envelope field, current intensity 2-4mA) | Device | Transcranial Current Stimulation (tTIS) Targeting Ventral Posterolateral Nucleus for Pain Treatment |
Primary outcome
Change from baseline in numerical rating scale (NRS) score
Time frame: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Patients are followed up and NRS score is determined. In general, the minimum and maximum scores of NRS are 0 and 10, respectively, with higher scores meaning a worse outcome.
7 secondary outcomes
Change from baseline in visual analog scale (VAS) score
Time frame: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in patient global impression of change (PGIC) score
Time frame: Immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in short-form McGill pain questionnaire (SF-MPQ) score
Time frame: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in Penn spasm frequency scale (PSFS) score
Time frame: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in Hamilton anxiety rating scale (HAMA) score
Time frame: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Change from baseline in Hamilton depression rating scale (HAMD) score
Time frame: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment
Adverse events
Time frame: Baseline up to 2 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10Hz tTIS (2-4mA) Intervention in people with NMO Spectrum Disorder, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun GUO, Dr ((86)13991269132, guojun_81@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in numerical rating scale (NRS) score (time frame: Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.