Brain as a Therapeutic and Research Target in Trigeminal Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in MOR BPND levels
研究概览
简要总结
The main goal of this study to integrate techniques producing images of the brain (also called neuroimaging techniques) with non-invasive brain stimulation to investigate factors that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).
详细描述
Trigeminal neuropathic pain (TNP) disorders, such as classical trigeminal and post-surgical neuralgia, are debilitating chronic conditions with pain that is either spontaneous or that can be intensely evoked by light touch to the facial skin. Although neuroimaging techniques have provided insights into some brain mechanisms of experimental trigeminal pain in humans (DaSilva et al., 2002; Borsook et al., 2003), it is not well understood how structural and molecular mechanisms are affected during the course of TNP, and how they can be safely modulated for therapeutic and research purposes. Understanding these processes is crucial to determine the structures engaged in the development and persistence of TNP.
We will test the hypothesis that chronicity of TNP is sustained by changes at cellular and molecular levels in neural circuits associated with pain perception and modulation, rather than by the initial peripheral etiology, and that this dysfunction can be safely targeted and modulated as a therapeutic approach by transcranial direct current stimulation (tDCS). To achieve this goal we will use a neuroimaging technique, PET, employing a mathematical model that permits the quantification of opioid receptor availability in vivo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Daily chronic TNP for at least 6 months not adequately controlled by pervious medicine therapies;
- •minimal average baseline pain score of 4 (moderate to severe) in the visual analogue scale (VAS);
- •unilateral pain
- •orofacial allodynic region to mechanical (light touch or palpation) or thermal stimulation (head or cold);
排除标准
- •pregnancy or planning to become pregnant
- •local pathology (e.g. orofacial lesion)
- •history of systemic disorders (e.g. MS)
- •history of other chronic pain disorder (e.g. back pain)
- •recent orofacial surgery or trauma (< 6 months)
- •history of central origin disorders (e.g. stroke)
研究组 & 干预措施
Refractory Trigeminal Neurpathic Pain (TNP) Patients
All patients receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
干预措施: PET Scans (Procedure)
Refractory Trigeminal Neurpathic Pain (TNP) Patients
All patients receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
干预措施: transcranial direct current stimulation (tDCS) (Procedure)
Refractory Trigeminal Neurpathic Pain (TNP) Patients
All patients receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
干预措施: MRI (Procedure)
Refractory Trigeminal Neurpathic Pain (TNP) Patients
All patients receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
干预措施: sham tDCS (prior to real tDCS) (Other)
Healthy volunteers
All volunteers receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
干预措施: PET Scans (Procedure)
Healthy volunteers
All volunteers receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
干预措施: transcranial direct current stimulation (tDCS) (Procedure)
Healthy volunteers
All volunteers receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
干预措施: MRI (Procedure)
Healthy volunteers
All volunteers receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.
干预措施: sham tDCS (prior to real tDCS) (Other)
结局指标
主要结局
Change in MOR BPND levels
时间窗: place weeks after not more than 6months
change from baseline to versus sham or active tDCS
次要结局
未报告次要终点
研究者
Alexandre DaSilva, DDS, MS
DDS, D.Med.Sc.
University of Michigan