Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061342) titled 'Ear and magnetic stimulation therapy for hand paralysis in spinal cord injury' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Saitama medical university
Condition:
Condition - cervical spinal cord injury
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To explore the efficacy and safety of occupational therapy combined with tVNS and rPMS on cervical spinal cord injury
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - rPMS and tVNS
Interventions/Control_2 - Standard occupational therapy
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1)Aged 20 years or older and less than 85 years
2)Within 1 month of injury onset
3)ASIA impairment scale A-C and severe key muscles disabilities of upper extremity correspond to MMT 1-2/5
4)JCS level I
5)Patients with no cognitive impairment (Mini-Mental State Examination [MMSE] > 24) who provide written informed consent voluntarily based on a full understanding of the study after receiving a detailed explanation regarding participation.
6)Stable physical state, and normal blood pressure
7)No fracture of target extremities
Key exclusion criteria - 1)Metallic implants in the body (including pacemakers, etc.)
2)Severe cardiac disease (myocardial infarction, angina pectoris, valvular disease, arrhythmia, etc.)
3)History of epilepsy
4)Pregnant or may be pregnant
5)Psychiatric or neurological disorders, or unstable general condition
6)Individuals who did not provide written informed consent or who withdrew consent
7)Individuals deemed unsuitable for the study by the principal investigator
Target Size - 32
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 20 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2030 Year 07 Month 14 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070187
Disclaimer: Curated by HT Syndication.
