Effects of long-term intervention with low-intensity transcranial focused ultrasound stimulation for neuropathic pain

Effects of long-term intervention with low-intensity transcranial focused ultrasound stimulation for neuropathic pain - TUS-P-02

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052240227

Enrollment

Registered

2024-12-27

Start date

2025-04-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic pain Neuropathic pain

Interventions

low-intensity transcranial focused ultrasound stimulation

Focused ultrasound, non-invasive brain stimulation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) neuropathic pain longer than 3 months after onset (2) Age >= 18 years (3) NRS of pain intensity at screening >= 4 (4) Patients with written consent for participation in this study

Exclusion criteria

Exclusion criteria: (1) Patients with dementia (MMSE<=23) (2) Patients with severe aphasia or cognitive dysfunction (3) Patients with severe mental illness (4) Patients with a history of epileptic seizures (5) Patients with implantable stimulators such as cardiac pacemaker (excluding implantable spinal cord stimulator) (6) Patients with metal (excluding titanium products) implants in the head (7) Patients with implantable medication devices or implantable ventricular assist devices (8) Pregnant patients (9) Patients unable to answer the questionnaires (10) Patients who enrolled in any other clinical trials within the last three months before obtaining consent (11) Others not applicable person determined by the investigators

Design outcomes

Primary

Measure	Time frame
Change in pain diary at each time point (weeks 1-8) compared to pre-intervention	—

Secondary

Measure	Time frame
(1) Change in pain NRS at each time point compared to pre-intervention (2) Change in SF-MPQ2 at each time point compared to pre-intervention (3) Change in BPI at week 8 compared to pre-intervention (4) Change in EQ-5D-5L at week 8 compared to pre-intervention (5) Change in HADS at week 8 compared to pre-intervention (6) Change in PCS at week 8 compared to pre-intervention (7) Change in PSEQ at week 8 compared to pre-intervention (8) Change in MMSE at week 8 compared to pre-intervention (9) Change in quantitative sensory testing (QST) at week 8 compared to pre-intervention (10) Change in MEP at week 8 compared to pre-intervention (11) Change in Shibire NRS at each time point (12) PGIC (Week 8) (13) Safety: adverse event (14) Blinding assessment	—

Measure

Time frame

(1) Change in pain NRS at each time point compared to pre-intervention (2) Change in SF-MPQ2 at each time point compared to pre-intervention (3) Change in BPI at week 8 compared to pre-intervention (4) Change in EQ-5D-5L at week 8 compared to pre-intervention (5) Change in HADS at week 8 compared to pre-intervention (6) Change in PCS at week 8 compared to pre-intervention (7) Change in PSEQ at week 8 compared to pre-intervention (8) Change in MMSE at week 8 compared to pre-intervention (9) Change in quantitative sensory testing (QST) at week 8 compared to pre-intervention (10) Change in MEP at week 8 compared to pre-intervention (11) Change in Shibire NRS at each time point (12) PGIC (Week 8) (13) Safety: adverse event (14) Blinding assessment

—

Contacts

Public ContactNobuhiko Mori

The University of Osaka Hospital

n-mori@nsurg.med.osaka-u.ac.jp+81-6-6879-3652

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026