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

NCT07377305 | Recruiting

• 1 other identifier: K202512-50
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NMO Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment

• Change from baseline in Penn spasm frequency scale (PSFS) score

  Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment

• Change from baseline in Hamilton anxiety rating scale (HAMA) score

  Baseline, immediately after 5 consecutive treatments, 1 week after treatment, 2 weeks after treatment

Study Arms (1)

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)

Device: 10Hz tTIS (2-4mA) Intervention

Interventions

10Hz tTIS (2-4mA) Intervention DEVICE

tTIS (10Hz envelope field, current intensity 2-4mA)

Transcranial Current Stimulation (tTIS) Targeting Ventral Posterolateral Nucleus for Pain Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 30 days before enrollment.
• Patients or their family members who have signed a written informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

Methods

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Jun GUO, Dr

CONTACT

(86)13991269132; guojun_81@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 29, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (1)