Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)

January 22, 2026 updated by: Jun Guo, MD, Tang-Du Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tangdu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transcranial Current Stimulation (tTIS) Targeting Ventral Posterolateral Nucleus for Pain Treatment
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)
Device: 10Hz tTIS (2-4mA) Intervention
tTIS (10Hz envelope field, current intensity 2-4mA)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
tTIS-related adverse events (AEs), such as headache, scalp irritation, rash, epilepsy, are evaluated and the rate of AEs is recorded.
Baseline up to 2 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K202512-50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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