Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062766) titled 'A study of neuropathic pain characteristics using electroencephalography and transcranial magnetic stimulation' on Sept. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Kio university
Condition:
Condition - Spinal cord injury, stroke, limb amputation, and brachial plexus injury; healthy adults as controls
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Neuropathic pain is thought to arise from a combination of impaired somatosensory input due to lesions of the somatosensory pathways and deafferentation, altered motor output including changes in corticospinal excitability, and abnormal resting-state brain networks. However, few studies have assessed these aspects simultaneously in the same individuals. The purpose of this study is to perform multimodal electrophysiological assessments (multichannel somatosensory evoked potentials (SEPs) and contact heat evoked potentials (CHEPs), corticospinal excitability and motor cortex mapping using transcranial magnetic stimulation (TMS), and network analysis of resting-state electroencephalography) in individuals with upper limb amputation, brachial plexus injury, spinal cord injury, or stroke, as well as in healthy adults, and to clarify how these measures correspond to the clinical features of neuropathic pain (evoked pain, musculoskeletal pain, and spontaneous pain). The findings will provide a basis for electrophysiologically informed selection of rehabilitation strategies according to symptom profiles.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Individuals aged 18 years or older who meet any of the following: (1) upper limb amputation, (2) brachial plexus injury, (3) spinal cord injury, (4) stroke, or (5) healthy adults as a control group. All participants must be able to understand the explanation of the study and to provide written informed consent of their own free will.
Key exclusion criteria - (1) Individuals unable to provide voluntary consent; (2) individuals for whom written informed consent cannot be obtained; (3) individuals with a history of epilepsy or judged to be at high risk of seizures (contraindication to transcranial magnetic stimulation); (4) individuals with intracranial metal, a cardiac pacemaker, a cochlear implant, or other implanted devices (contraindication to transcranial magnetic stimulation); (5) women who are pregnant or may be pregnant; (6) individuals with skin lesions or wounds at the stimulation sites; (7) individuals judged unsuitable for participation by the principal investigator.
Target Size - 130
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 01 Day
Anticipated trial start date - 2026 Year 11 Month 01 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071863
Disclaimer: Curated by HT Syndication.