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

JRCT ID: jRCTs052240227

Registered date:27/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neuropathic pain
• Date of first enrollment: 27/12/2024
• Target sample size: 39
• Study type: Interventional
• Intervention(s): low-intensity transcranial focused ultrasound stimulation

Outcome(s)

• Primary Outcome: Change in pain diary at each time point (weeks 1-8) compared to pre-intervention

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 with complete motor paralysis of the upper extremity and lowe extremity to be treated
(11) Patients who enrolled in any other clinical
trials within the last three months before obtaining
consent
(12) Others not applicable person determined by the investigators

Related Information

• Primary Sponsor: Hosomi Koichi