Tokyo, July 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058559) titled 'Experimental Study of Sensory and Motor Modulation Using Non-invasive Electrical Stimulation to Recover Spinal Cord Function' on July 23.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Waseda University
Condition:
Condition - Healthy
Spinal Cord Injury
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Transcutaneous spinal cord stimulation (tSCS) applied alone has been shown to increase motor evoked potential (MEP) amplitude, suggesting it enhances corticospinal tract excitability. high-frequency paired associative stimulation (h-PAS), which synchronizes transcranial magnetic stimulation (TMS) with high-frequency peripheral stimulation, is believed to promote neural reorganization by precisely timing the stimulation of motor pathways from the brain to the periphery.
This study aims to compare the effects of tSCS and h-PAS on physiological motor and sensory changes and on limb motor performance (muscle strength and dexterity) in healthy participants and individuals with spinal cord injury.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - After setting the stimulation intensity beforehand, we will apply electrical stimulation to the cervical region using transcutaneous spinal cord stimulation (tSCS), and measure electroencephalography (EEG) and electromyography (EMG) before and after the intervention.
Interventions/Control_2 - After setting the stimulation intensity beforehand, we will apply electrical stimulation to the cervical region using high-frequency paired associative stimulation (h-PAS), and measure electroencephalography (EEG) and electromyography (EMG) before and after the intervention.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Inclusion Criteria for Individuals with Spinal Cord Injury
Participants must have obtained permission from their attending physician to receive the electrical stimulation intervention.
Key exclusion criteria - a) Presence of metallic implants in the body (excluding titanium).
b) Presence of implanted electronic or metallic devices, such as a pacemaker.
c) History of epileptic seizures.
d) Current or suspected pregnancy.
Target Size - 21
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2030 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066958
Disclaimer: Curated by HT Syndication.