Evaluation of the brain functional connectivity networks using functional near infrared spectroscopy (fNIRS) in patients with trigeminal neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Brain activity and functional connectivity networks at resting state.
研究概览
简要总结
For the primary objective of the study, the baseline fNIRS of healthy volunteers and patients with TN having NRS/BNI > 4 will be compared at rest. While recording fNIRS in patients with TN, spontaneous pain may get elicited due to touching the face or by talking or cold breeze. We will record this data as fNIRS during pain. Over a period of time, with disease progression, these patients may require intervention in the form of RFA. We will perform fNIRS for these patients after RFA when they come for follow up.
Prior to RFA, a 5-minute recording of HRV will be performed at resting condition. HRV will be repeated post-RFA when patients come for follow up. The QOL, sleep and HADS will be assessed at the same time points as HRV.
Data Collection (from medical records):
Demographics: Age and gender.
History: duration of TN, distribution of pain, side affected, description of the type of pain, number of episodes of pain/day, BNI score, NRS score, medications received by the patients, any history of autonomic symptoms (sweating, diarrhea/constipation, tearing in the eyes etc.), triggers of pain
Before and after RFA (i.e., 4-6 weeks after RFA):
Assessment of QoL using European Quality of Life – 5D-5L dimension scale
Assessment of sleep quality using Sleep using Richards-Campbell Sleep Questionnaire
Assessment of anxiety and depression using HADS
MRI findings
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria for patients with Trigeminal Neuralgia (TN): Patients with diagnosis of TN with significant pain, i.e., Barrow Neurological Institute scale score (BNI) of 4 and 5) and giving consent for functional near infrared spectroscopy (fNIRS) and heart rate variability (HRV) recordings.
- •Patients who are likely to undergo radiofrequency ablation (RFA) and are unwilling for surgery for treatment of TN, (when patients are refractory to medical management by atleast 2 drugs of optimal dose or developed side effects to drugs) in future, will be recruited in to the study.
- •Inclusion criteria for controls: Age and gender matched volunteers, aged 35-60 years of both sexes will be included as controls.
排除标准
- •Exclusion criteria: Absence of patient consent, inability to perform fNIRS or HRV studies, patients who are likely to undergo surgery or gamma knife radiosurgery for treatment of TN if pain persists.
- •For controls: Volunteers with any type of chronic pain or if they are on any medications which can modulate the brain connectivity patterns will be excluded.
结局指标
主要结局
Brain activity and functional connectivity networks at resting state.
时间窗: At visit to pain clinic
次要结局
- 1. Brain functional connectivity networks in patients with TN during spontaneously evoked pain states.(2. Change in functional connectivity networks in patients with TN before and after RFA.)
研究者
Dr Sonia Bansal
NIMHANS