JRCT ID: jRCTs052230116
Registered date:23/10/2023
Perceptual modification using low-intensity transcranial focused ultrasound for neuropathic pain
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Neuropathic pain |
Date of first enrollment | 24/11/2023 |
Target sample size | 24 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | low-intensity transcranial focused ultrasound stimulation |
Outcome(s)
Primary Outcome | The amount of change in somatosensory threshold (assessed by Quantitative Sensory Testing (QST)) before and after each intervention |
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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 |
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Age maximum | Not applicable |
Gender | Both |
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
Primary Sponsor | Haruhiko Kishima |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Mori Nobuhiko |
Address | 2-15 Yamadaoka, Suita, Osaka Osaka Japan 565-0871 |
Telephone | +81-6-6879-3652 |
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 |
hkishima@nsurg.med.osaka-u.ac.jp | |
Affiliation | Osaka University Hospital |