Phase 2: Effects of Zolmitriptan on Sensory Afferent Transmission After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Cutaneomuscular Reflex Responses from baseline
研究概览
简要总结
After spinal cord injury, patients develop a spastic syndrome that is characterized by hyperactive reflexes, increased muscle tone, clonus and involuntary muscle spasms. The neuronal mechanisms behind the development of spasticity remain largely unknown, though animal experiments have shown that changes occur both at the level of the motoneuron and sensory neurons. This project aims to examine the changes that occur in the modulation of sensory afferent transmission after spinal cord injury, and how these changes can contribute to the triggering and initiation of muscle spasms after chronic spinal cord injury in humans.
It is known that after spinal cord injury, the majority of descending sources of monoamines, such as serotonin (5HT), are abolished. Animal experiments have shown that 5HT receptors on sensory neurons in the spinal cord are responsible for inhibiting sensory transmission. As a result, after spinal cord injury these receptors are no longer activated below an injury, resulting in the production of large, long excitatory responses in the motoneuron when sensory are activated. This large sensory activation of the motoneuron can, in turn, activate a long response in the motoneuron to produce an involuntary muscle spasm. The aim of our study is to determine whether, similar to animal experiments, the 5HT1 receptors are responsible for sensory inhibition in spinal cord injured subjects, and whether activating these receptors (through the 5HT1 agonist Zolmitriptan) will restore the normal inhibition of sensory transmission that is lost after injury, thereby resulting in a decrease in the initiation of involuntary muscle spasms.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must have suffered a trauma to the spinal cord at least 1 year prior. In addition, subjects must exhibit some degree of spasticity as determined by having an Ashworth Spasticity Score greater than 1 in the ankle or knee.
排除标准
- •If patients have damage to the nervous system other than to the spinal cord
- •Pregnant women
- •Elderly Patients (> 65 years)
- •Alcoholic Patients
- •History of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
- •Valvular heart disease or cardiac arrhythmias
- •Other significant underlying cardiovascular disease (atherosclerotic disease, congenital heart disease)
- •Uncontrolled or severe hypertension
- •Hemiplegic, basilar or ophthalmologic migraine
- •Hypersensitivity to Zolmitriptan or any component of the formulation
- •History of Autonomic Dysreflexia
- •Patients taking:
- •Ergot-containing drugs
- •Other 5HT1 Agonists
- •MAO Inhibitors
- •Cimetidine and other 1A2 Inhibitors
- •Propranolol
- •Selective Serotonin and Norepinephrine Reuptake Inhibitors
- •Acetaminophen
- •Metoclopramide
- •Xylometazoline
- •Oral Contraceptives
结局指标
主要结局
Change in Cutaneomuscular Reflex Responses from baseline
时间窗: Pre baseline, 30, 60, 90, 120 minutes
Tibialis anterior reflex responses will be recorded after medial arch stimulation of the foot. Recordings will be taken to provide a pre-drug baseline and then every 30 minutes after drug intake up to 2 hrs to determine the change in these reflex responses after drug intake.
Change in H-reflex amplitude from baseline
时间窗: Pre baseline, 30, 60, 90 and 120 minutes
H-reflexes in the soleus muscle will be evoked by stimulation of the posterior tibial nerve. The response will recorded before drug intake, and every 30 minutes after drug intake up to 2 hours to determine the change in the response as a result of drug intake.
次要结局
- Change in Heart rate(Predrug, 60min and 120min after drug)
- Change in Blood pressure(Pre and 60min, 120min post drug)