NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052230116

Registered date:23/10/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedNeuropathic pain
Date of first enrollment24/11/2023
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)low-intensity transcranial focused ultrasound stimulation

Outcome(s)

Primary OutcomeThe amount of change in somatosensory threshold (assessed by Quantitative Sensory Testing (QST)) before and after each intervention
Secondary Outcome(1) The amount of change in motor evoked potentials (MEPs) before and after each intervention (2) Change in pain intensity (NRS) before and after each intervention (3) The amount of change in the McGill Pain Questionnaire, Short Form Version 2 (SF-MPQ2) score before and after each intervention (4) The amount of change in the degree of numbness before and after each intervention (5) Patient General Impression Criteria (PGIC) after each intervention (6) Adverse events

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include 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
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 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

Contact

Public contact
Name Mori Nobuhiko
Address 2-15 Yamadaoka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3652
E-mail n-mori@nsurg.med.osaka-u.ac.jp
Affiliation Osaka University Hospital
Scientific contact
Name Kishima Haruhiko
Address 2-15 Yamadaoka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3652
E-mail hkishima@nsurg.med.osaka-u.ac.jp
Affiliation Osaka University Hospital