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

JRCT ID: jRCTs052230116

Registered date:23/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neuropathic pain
• Date of first enrollment: 24/11/2023
• Target sample size: 24
• 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

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 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