Project SCIN (Spinal Cord Injury Neurosexuality) - Developing a Biological Understanding of Sexual Health following Spinal Cord Injury using fMRI

South Australian Health and Medical Research Institute0 个研究点目标入组 48 人开始时间: 2022年5月23日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•SCI participants (Cohort 1)
•Have a traumatic or non-traumatic SCI or disease, or a spinal cord syndrome (Central Cord Syndrome, Brown-Sequard Syndrome, Anterior Cord Syndrome) > 2 years post injury.
•Have complete or incomplete SCI, and Grade A, Grade B, or Grade C classification confirmed on physical examination, conductance in accordance with the International Standard for the Neurological Classification of SCI (ISNCSCI) 2019 revision.
•Have neurological level between C4 and T12 on physical examination (ISNCSCI 2019 revision);
•Are medically stable and have no contraindication to MRI in the opinion of the treating physician;
•Are agreeable to answer questions about their sexuality, mental and physical arousal.
•Are able to abstain from taking sexual enhancing medications such as sildenafil (Viagra), tadalafil (cialis) and vardenafil (Levitra, or BP101 for at least 72 hours prior to each study visit
•Able-bodied participants (Cohort 2)
•Have no medical history of traumatic or non-traumatic SCI, or spinal cord syndrome
•Medically stable (in the opinion of the Study Doctor).
•Be willing to answer questions about your sexuality and individual levels of mental and physical arousal
•Are able to abstain from taking sexual enhancing medications such as sildenafil (Viagra), tadalafil (cialis) and vardenafil (Levitra, or BP101 for at least 72 hours prior to each study visit

•Have medical history of stroke, traumatic brain injury (TBI), Parkinson’s Disease, Multiple sclerosis, brachial plexus lesion, syrinx, or any other serious neurological condition;
•Have medical history of malignancy, psychiatric illness, or illicit drug-dependence;
•Have active osteomyelitis of vertebral bone, Paget’s disease, or severe spinal deformity;
•Have contraindication(s) to fMRI imaging; (e.g., poorly controlled spasticity, autonomic dysreflexia, pressure ulcer(s) or another medical condition) advised by the treating physician;
•Have participated in investigational drug study within 30 days of enrolment;
•Have in situ instrumentation (carbon fibre, or metal fixation) incompatible with fMRI in the opinion of the radiologist.
•Are considered unwilling, unable or unlikely to comply with the study protocol
•Have English language competency insufficient to understand research procedures, or are unable to provide informed consent.

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