Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061640) titled 'The effects of vibration-based rehabilitation interventions on brain activity and sensory function for neuropathic pain after spinal cord injury' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Kio University
Condition:
Condition - healthy person
patients with neuropathic pain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - By verifying the effectiveness of rehabilitation interventions using vibration stimulation and clarifying the relationship between sensory function recovery and changes in brain activity, we aim to obtain insights that will contribute to establishing effective rehabilitation approaches for neuropathic pain after spinal cord injury.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Electroencephalography (EEG) is used for physiological evaluation to detect pain-related EEG activity.
In healthy subjects, vibration stimulation intervention is performed 6-7 times per week for one week within the framework of standard rehabilitation using a customized vibration stimulation device.
Interventions/Control_2 - Physiological evaluation is performed using electroencephalography (EEG) to detect pain-related EEG activity.
In patients with neuropathic pain, vibration stimulation intervention is performed 6-7 times per week for one week within the framework of regular rehabilitation using a customized vibration stimulation device. The vibration stimulation site is basically the index and middle finger pads on the side where neuropathic pain is not present (or the side with less pain subjectively if it occurs bilaterally), and is applied for 10 minutes. The stimulation intensity is 10Hz, 20Hz, or a frequency that the patient finds comfortable.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - healthy patients
patients with neuropathic pain
Key exclusion criteria - healthy patients
1.Individuals lacking the capacity to give voluntary consent.
2.Individuals for whom written research consent cannot be obtained.
3.Individuals without neurological or mental disorders or chronic pain.
4.Individuals who have taken analgesics within 12 hours of the experiment.
Patients with neuropathic pain
1.Individuals lacking the capacity to give voluntary consent.
2.Individuals for whom written research consent cannot be obtained.
3.Individuals with severe cognitive impairment, comorbid mental illness, or severe complications that would affect the conduct of the research.
Target Size - 5
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 20 Day
Anticipated trial start date - 2026 Year 05 Month 21 Day
Last follow-up date - 2027 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070505
Disclaimer: Curated by HT Syndication.