Pathophysiological Mechanisms of Trigeminal Neuralgia - Neurophysiological Assessment of the Blink-reflex
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Latency and amplitude of blink reflex on the pain side of classical trigeminal neuralgia patients.
研究概览
简要总结
This study aims to increase the understanding of the pathophysiology of trigeminal neuralgia by investigating the potential association between blink reflex abnormalities and phenotypical traits e.g. clinical characteristics and neuroimaging findings.
详细描述
We hypothesize:
Patients with classical trigeminal neuralgia have a prolonged latency and reduced amplitudes of the blink-reflex on the pain side compared to patients with idiopathic TN
The latency and amplitudes of the blink-reflex is normal in patients with idiopathic trigeminal neuralgia
Patients with concomitant persistent pain have a prolonged latency and reduced amplitudes of the blink reflex on the pain side compared to patients with pure paroxysmal TN
More men than women have a prolonged latency and reduced amplitudes of the blink reflex
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes with trigeminal neuralgia must meet the following inclusion criteria to be eligible for participation:
- •Age 18 years or older
- •Must be able to give Signed Informed Consent prior to study entry. Appendix X
- •Must fulfill the ICHD-3 diagnostic criteria1 for classical, idiopathic or secondary TN.
- •Has had a 3.0 Tesla MRI according to the trigeminal neuralgia protocol, maximum 2 years before or after the assessment of the blink-reflex.
- •Has had a semi-structured interview and neurological examination by the independent assessors, maximum 2 years before or after the assessment of the blink-reflex.
排除标准
- •Subjects will be excluded if one of the following exclusion criteria is met:
- •If the patient is not able to give informed consent due to mental challenges
- •Previous neurosurgical treatment (microvascular decompression and/or ablative procedures) for trigeminal neuralgia
- •Bilateral trigeminal neuralgia
- •Symptomatic trigeminal neuralgia
- •Findings of sensory abnormalities detected at clinical neurological examination
结局指标
主要结局
Latency and amplitude of blink reflex on the pain side of classical trigeminal neuralgia patients.
时间窗: 1 year
We place the stimulator above the emergence of the supraorbital nerve, with the distal pole placed below. The subject could be in a sitting or supine position. He keeps his eyes opened and relaxed. The final intensity of stimulation is generally between 5to 10mA, but higher intensities sometime are required. We don't start from this intensity, but we increase it gradually from 2mA, in steps of 1-2mA. The time between consecutive stimuli must not be under 45 seconds, in order to avoid habituation. Before the stimuli is delivered, we look at the real-time activity box to be sure that the subject is relaxed. We aim to record at least 2-3 consecutive sweeps with a stable latency of the R1 and R2 components.
次要结局
- Latency and amplitude of blink reflex on the pain side of idiopathic trigeminal neuralgia patients(1 year)
研究者
Henrik Schytz
Consultant in Neurology
Danish Headache Center