Perceptual modification using low-intensity transcranial focused ultrasound for neuropathic pai

Phase 1

Recruiting

• Conditions: europathic pain; Neuropathic pain; MG30.5

• Registration Number: JPRN-jRCTs052230116
• Lead Sponsor: Haruhiko Kishima

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-23
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

(1) Patients with neuropathic pain longer than 3 months after onset
(2) Patients with continuous pain at upper extremity
(3) Age >= 18 years
(4) Patients with written consent for participation in this study

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 with complete motor paralysis of the upper 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The amount of change in somatosensory threshold (assessed by Quantitative Sensory Testing (QST)) before and after each intervention

Secondary Outcome Measures

Name	Time	Method
(1) The amount of change in motor evoked potentials (MEPs) before and after each intervention<br>(2) Change in pain intensity (NRS) before and after each intervention<br>(3) The amount of change in the McGill Pain Questionnaire, Short Form Version 2 (SF-MPQ2) score before and after each intervention<br>(4) The amount of change in the degree of numbness before and after each intervention<br>(5) Patient General Impression Criteria (PGIC) after each intervention<br>(6) Adverse events